Systems for detecting proximity of surgical end effector to cancerous tissue

ABSTRACT

A surgical instrument includes an end effector having a first jaw, a second jaw movable relative to the first jaw to grasp tissue therebetween, an anvil, a staple cartridge comprising staples deployable into the tissue, wherein the staples are deformable by the anvil, and a sensor configured to provide a sensor signal according to a physiological parameter of the tissue. The surgical instrument further includes a control circuit coupled to the sensor, wherein the control circuit is configured to receive the sensor signal, and assess proximity of the sensor to cancerous tissue based on the sensor signal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119(e)to U.S. Provisional Patent Application Ser. No. 62/691,227, titledCONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSUREPARAMETERS, filed Jun. 28, 2018, the disclosure of which is hereinincorporated by reference in its entirety.

This application claims the benefit of priority under 35 U.S.C. § 119(e)to U.S. Provisional Patent Application Ser. No. 62/650,887, titledSURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES, filed Mar. 30,2018, to U.S. Provisional Patent Application Ser. No. 62/650,877, titledSURGICAL SMOKE EVACUATION SENSING AND CONTROLS, filed Mar. 30, 2018, toU.S. Provisional Patent Application Ser. No. 62/650,882, titled SMOKEEVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filed Mar. 30,2018, and to U.S. Provisional Patent Application Ser. No. 62/650,898,titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS,filed Mar. 30, 2018, the disclosure of each of which is hereinincorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/640,417,titled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR, filed Mar. 8, 2018, and to Provisional Patent Application Ser.No. 62/640,415, titled ESTIMATING STATE OF ULTRASONIC END EFFECTOR ANDCONTROL SYSTEM THEREFOR, filed Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/611,341,titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, to U.S.Provisional Patent Application Ser. No. 62/611,340, titled CLOUD-BASEDMEDICAL ANALYTICS, filed Dec. 28, 2017, and to U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

The present disclosure relates to various surgical systems.

SUMMARY

A surgical instrument is disclosed. The surgical instrument comprises anend effector and a control circuit. The end effector comprises a firstjaw, a second jaw movable relative to the first jaw to grasp tissuetherebetween, an anvil, a staple cartridge comprising staples deployableinto the tissue, wherein the staples are deformable by the anvil, and asensor configured to provide a sensor signal according to aphysiological parameter of the tissue. The control circuit is coupled tothe sensor, wherein the control circuit is configured to receive thesensor signal, and assess proximity of the sensory to cancerous tissuebased on the sensor signal.

A surgical stapling instrument is disclosed. The surgical staplinginstrument comprises an end effector and a control circuit. The endeffector comprises a first jaw, a second jaw movable relative to thefirst jaw to grasp tissue therebetween, an anvil, a staple cartridgecomprising staples deployable into the tissue, wherein the staples aredeformable by the anvil, and a sensor configured to provide a sensorysignal according to a physiological parameter indicative of proximity ofthe sensor to cancerous tissue. The control circuit is coupled to thesensor, wherein the control circuit is configured to receive the sensorsignal, determine a value of the physiological parameter based on thesensor signal, and compare the value of the physiological parameter to apredetermined threshold.

A surgical instrument is disclosed. The surgical instrument comprises anend effector and a control circuit. The end effector comprises a firstjaw, a second jaw movable relative to the first jaw to grasp tissuetherebetween, an anvil, a staple cartridge comprising staples deployableinto the tissue, wherein the staples are deformable by the anvil, and asensor assembly configured to provide sensor signals according to aphysiological parameter indicative of proximity of the sensors tocancerous tissue. The sensor assembly comprises a first sensor on afirst side of a longitudinal axis extending through the staple cartridgeand a second sensor on a second side of the longitudinal axis. Thecontrol circuit is coupled to the sensor assembly, wherein the controlcircuit is configured to receive a first sensor signal from the firstsensor, receive a second sensor signal from the second sensor, determinea first value of the physiological parameter based on the first sensorsignal, determine a second value of the physiological parameter based onthe second sensor signal, and compare the first value and the secondvalue to a predetermined threshold.

FIGURES

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 13 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 14 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 15 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure.

FIG. 18 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 19 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 20 is a schematic illustration of a tissue contact circuit showingthe completion of the circuit upon contact of tissue with a pair ofspaced-apart contact plates, in accordance with at least one aspect ofthis disclosure.

FIG. 21 is a perspective view of a surgical instrument that has aninterchangeable shaft assembly operably coupled thereto, in accordancewith at least one aspect of this disclosure.

FIG. 22 is an exploded assembly view of a portion of the surgicalinstrument of FIG. 21, in accordance with at least one aspect of thisdisclosure.

FIG. 23 is an exploded assembly view of portions of the interchangeableshaft assembly, in accordance with at least one aspect of thisdisclosure.

FIG. 24 is an exploded view of an end effector of the surgicalinstrument of FIG. 21, in accordance with at least one aspect of thisdisclosure.

FIG. 25A is a block diagram of a control circuit of the surgicalinstrument of FIG. 21 spanning two drawing sheets, in accordance with atleast one aspect of this disclosure.

FIG. 25B is a block diagram of a control circuit of the surgicalinstrument of FIG. 21 spanning two drawing sheets, in accordance with atleast one aspect of this disclosure.

FIG. 26 is a block diagram of the control circuit of the surgicalinstrument of FIG. 21 illustrating interfaces between the handleassembly, the power assembly, and the handle assembly and theinterchangeable shaft assembly, in accordance with at least one aspectof this disclosure.

FIG. 27 illustrates a tumor surrounded by healthy tissue, and a clearmargin defined in the healthy tissue, in accordance with at least oneaspect of the present disclosure.

FIG. 28 is a graph illustrating of a physiological parameter of tissueplotted against distance from a tumor, in accordance with at least oneaspect of the present disclosure.

FIG. 29 is a logic flow diagram of a process depicting a control programor a logic configuration for assessing proximity of an end effector of asurgical instrument to cancerous tissue, in accordance with at least oneaspect of the present disclosure.

FIG. 30 illustrates a logic flow diagram of a process depicting acontrol program or a logic configuration for assessing proximity of anend effector to cancerous tissue, in accordance with at least one aspectof the present disclosure.

FIG. 31 illustrates an end effector of a surgical instrument, inaccordance with at least one aspect of the present disclosure.

FIG. 32 illustrates a control system of a surgical instrument, inaccordance with at least one aspect of the present disclosure.

FIG. 33 illustrates a proximity index correlating a sensor signal toproximity from an end effector, in accordance with at least one aspectof the present disclosure.

FIG. 34 illustrates a logic flow diagram of a process depicting acontrol program or a logic configuration for determining the directionat which cancerous tissue is located with respect to an end effector, inaccordance with at least one aspect of the present disclosure.

FIG. 35 illustrates a top view of an end effector of a surgicalinstrument, in accordance with at least one aspect of the presentdisclosure.

FIG. 36 is a graph illustrating sensor signals representing aphysiological parameter of tissue plotted against time, in accordancewith at least one aspect of the present disclosure.

FIG. 37 illustrates a partial view of an end effector of a surgicalinstrument, in accordance with at least one aspect of the presentdisclosure.

FIG. 38 is a graph illustrating sensor signals representing aphysiological parameter of tissue plotted against time, in accordancewith at least one aspect of the present disclosure.

FIG. 39 is a logic flow diagram of a process depicting a control programor a logic configuration for providing instructions for navigating anend effector with respect to cancerous tissue, in accordance with atleast one aspect of the present disclosure.

FIG. 40 is a logic flow diagram of a process depicting a control programor a logic configuration for providing instructions for navigating anend effector with respect to cancerous tissue, in accordance with atleast one aspect of the present disclosure.

FIG. 41 is a graph illustrating sensor signals representing aphysiological parameter of tissue plotted against time, in accordancewith at least one aspect of the present disclosure. Error! No sequencespecified.

FIG. 42 illustrates a glucose sensor, in accordance with at least oneaspect of the present disclosure.

FIG. 43 illustrates an expanded view of the glucose sensor of FIG. 42.

FIG. 44 is a graph illustrating Current plotted against Potential, inaccordance with at least one aspect of the present disclosure.

FIG. 45 is a graph illustrating Net Current plotted against Glucoselevel, in accordance with at least one aspect of the present disclosure.

FIG. 46 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. PatentApplications, filed on Jun. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

U.S. patent application Ser. No. ______, titled CAPACITIVE COUPLEDRETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, Attorney Docket No.END8542USNP/170755;

U.S. patent application Ser. No. ______, titled CONTROLLING A SURGICAL

INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS, Attorney Docket No.END8543USNP/170760;

U.S. patent application Ser. No. ______, titled SYSTEMS FOR ADJUSTINGEND EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION, AttorneyDocket No. END8543USNP1/170760-1;

U.S. patent application Ser. No. ______, titled SAFETY SYSTEMS FOR SMARTPOWERED SURGICAL STAPLING, Attorney Docket No. END8543USNP2/170760-2;

U.S. patent application Ser. No. ______, titled SAFETY SYSTEMS FOR SMARTPOWERED SURGICAL STAPLING, Attorney Docket No. END8543USNP3/170760-3;

U.S. patent application Ser. No. ______, titled SURGICAL SYSTEMS FORDETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES, AttorneyDocket No. END8543USN P4/170760-4;

U.S. patent application Ser. No. ______, titled SURGICAL INSTRUMENTCARTRIDGE SENSOR ASSEMBLIES, Attorney Docket No. END8543USNP6/170760-6;

U.S. patent application Ser. No. ______, titled VARIABLE OUTPUTCARTRIDGE SENSOR ASSEMBLY, Attorney Docket No. END8543USNP7/170760-7;

U.S. patent application Ser. No. ______, titled SURGICAL INSTRUMENTHAVING A FLEXIBLE ELECTRODE, Attorney Docket No. END8544USNP/170761;

U.S. patent application Ser. No. ______, titled SURGICAL INSTRUMENTHAVING A FLEXIBLE CIRCUIT, Attorney Docket No. END8544USNP1/170761-1;

U.S. patent application Ser. No. ______, titled SURGICAL INSTRUMENT WITHA TISSUE MARKING ASSEMBLY, Attorney Docket No. END8544USNP2/170761-2;

U.S. patent application Ser. No. ______, titled SURGICAL SYSTEMS WITHPRIORITIZED DATA TRANSMISSION CAPABILITIES, Attorney Docket No.END8544USNP3/170761-3;

U.S. patent application Ser. No. ______, titled SURGICAL EVACUATIONSENSING AND MOTOR CONTROL, Attorney Docket No. END8545USNP/170762;

U.S. patent application Ser. No. ______, titled SURGICAL EVACUATIONSENSOR ARRANGEMENTS, Attorney Docket No. END8545USNP1/170762-1;

U.S. patent application Ser. No. ______, titled SURGICAL EVACUATION FLOWPATHS, Attorney Docket No. END8545USNP2/170762-2;

U.S. patent application Ser. No. ______, titled SURGICAL EVACUATIONSENSING AND GENERATOR CONTROL, Attorney Docket No.END8545USNP3/170762-3;

U.S. patent application Ser. No. ______, titled SURGICAL EVACUATIONSENSING AND DISPLAY, Attorney Docket No. END8545USNP4/170762-4;

U.S. patent application Ser. No. ______, titled COMMUNICATION OF SMOKEEVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULEFOR INTERACTIVE SURGICAL PLATFORM, Attorney Docket No.END8546USNP/170763;

U.S. patent application Ser. No. ______, titled SMOKE EVACUATION SYSTEMINCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM,Attorney Docket No. END8546USNP1/170763-1;

U.S. patent application Ser. No. ______, titled SURGICAL EVACUATIONSYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTERAND A SMOKE EVACUATION DEVICE, Attorney Docket No. END8547USNP/170764;and

U.S. patent application Ser. No. ______, titled DUAL IN-SERIES LARGE ANDSMALL DROPLET FILTERS, Attorney Docket No. END8548USNP/170765.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Jun. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/691,228, titled A METHODOF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITHELECTROSURGICAL DEVICES;

U.S. Provisional Patent Application Ser. No. 62/691,227, titledCONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSUREPARAMETERS;

U.S. Provisional Patent Application Ser. No. 62/691,230, titled SURGICALINSTRUMENT HAVING A FLEXIBLE ELECTRODE;

U.S. Provisional Patent Application Ser. No. 62/691,219, titled SURGICALEVACUATION SENSING AND MOTOR CONTROL;

U.S. Provisional Patent Application Ser. No. 62/691,257, titledCOMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD INSMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;

U.S. Provisional Patent Application Ser. No. 62/691,262, titled SURGICALEVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEENA FILTER AND A SMOKE EVACUATION DEVICE; and

U.S. Provisional Patent Application Ser. No. 62/691,251, titled DUALIN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE SURGICALSYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;

U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE SURGICALSYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES;

U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUBCOORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES;

U.S. patent application Ser. No. 15/940,666, titled SPATIAL AWARENESS OFSURGICAL HUBS IN OPERATING ROOMS;

U.S. patent application Ser. No. 15/940,670, titled COOPERATIVEUTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENTSURGICAL HUBS;

U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB CONTROLARRANGEMENTS;

U.S. patent application Ser. No. 15/940,632, titled DATA STRIPPINGMETHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD;

U.S. patent application Ser. No. 15/940,640, titled COMMUNICATION HUBAND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICALDEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS;

U.S. patent application Ser. No. 15/940,645, titled SELF DESCRIBING DATAPACKETS GENERATED AT AN ISSUING INSTRUMENT;

U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING TOINTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;

U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUBSITUATIONAL AWARENESS;

U.S. patent application Ser. No. 15/940,663, titled SURGICAL SYSTEMDISTRIBUTED PROCESSING;

U.S. patent application Ser. No. 15/940,668, titled AGGREGATION ANDREPORTING OF SURGICAL HUB DATA;

U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB SPATIALAWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;

U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF ALIGNMENTOF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;

U.S. patent application Ser. No. 15/940,700, titled STERILE FIELDINTERACTIVE CONTROL DISPLAYS;

U.S. patent application Ser. No. 15/940,629, titled COMPUTER IMPLEMENTEDINTERACTIVE SURGICAL SYSTEMS;

U.S. patent application Ser. No. 15/940,704, titled USE OF LASER LIGHTAND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTEREDLIGHT;

U.S. patent application Ser. No. 15/940,722, titled CHARACTERIZATION OFTISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHTREFRACTIVITY; and

U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS ARRAYIMAGING. Applicant of the present application owns the following U.S.Patent Applications, filed on Mar. 29, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE CONTROLPROGRAM UPDATES FOR SURGICAL DEVICES;

U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE CONTROLPROGRAM UPDATES FOR SURGICAL HUBS;

U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED MEDICALANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER;

U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED MEDICALANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCEACQUISITION BEHAVIORS OF LARGER DATA SET;

U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED MEDICALANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENTFUNCTION;

U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED MEDICALANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES;

U.S. patent application Ser. No. 15/940,706, titled DATA HANDLING ANDPRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and

U.S. patent application Ser. No. 15/940,675, titled CLOUD INTERFACE FORCOUPLED SURGICAL DEVICES.

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

U.S. patent application Ser. No. 15/940,627, titled DRIVE ARRANGEMENTSFOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,637, titled COMMUNICATIONARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,642, titled CONTROLS FORROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC TOOLADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS FORROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE SURGICALACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,690, titled DISPLAY ARRANGEMENTSFOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

U.S. patent application Ser. No. 15/940,711, titled SENSING ARRANGEMENTSFOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/649,302, titledINTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;

U.S. Provisional Patent Application Ser. No. 62/649,294, titled DATASTRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZEDRECORD;

U.S. Provisional Patent Application Ser. No. 62/649,300, titled SURGICALHUB SITUATIONAL AWARENESS;

U.S. Provisional Patent Application Ser. No. 62/649,309, titled SURGICALHUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;

U.S. Provisional Patent Application Ser. No. 62/649,310, titled COMPUTERIMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;

U.S. Provisional Patent Application Ser. No. 62/649,291, titled USE OFLASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OFBACK SCATTERED LIGHT;

U.S. Provisional Patent Application Ser. No. 62/649,296, titled ADAPTIVECONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;

U.S. Provisional Patent Application Ser. No. 62/649,333, titledCLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO AUSER;

U.S. Provisional Patent Application Ser. No. 62/649,327, titledCLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS ANDREACTIVE MEASURES;

U.S. Provisional Patent Application Ser. No. 62/649,315, titled DATAHANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;

U.S. Provisional Patent Application Ser. No. 62/649,313, titled CLOUDINTERFACE FOR COUPLED SURGICAL DEVICES;

U.S. Provisional Patent Application Ser. No. 62/649,320, titled DRIVEARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Provisional Patent Application Ser. No. 62/649,307, titledAUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

U.S. Provisional Patent Application Ser. No. 62/649,323, titled SENSINGARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. ProvisionalPatent Application, filed on Apr. 19, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/659,900, titled METHODOF HUB COMMUNICATION.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/650,887, titled SURGICALSYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;

U.S. Provisional Patent Application Ser. No. 62/650,877, titled SURGICALSMOKE EVACUATION SENSING AND CONTROLS;

U.S. Provisional Patent Application Ser. No. 62/650,882, titled SMOKEEVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and

U.S. Provisional Patent Application Ser. No. 62/650,898, titledCAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/640,417, titledTEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR;and

U.S. Provisional Patent Application Ser. No. 62/640,415, titledESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Dec. 28, 2017, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/611,341, titledINTERACTIVE SURGICAL PLATFORM;

U.S. Provisional Patent Application Ser. No. 62/611,340, titledCLOUD-BASED MEDICAL ANALYTICS; and

U.S. Provisional Patent Application Ser. No. 62/611,339, titled ROBOTASSISTED SURGICAL PLATFORM.

Before explaining various aspects of surgical devices and systems indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations, and modifications and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Aspects of the present disclosure present various surgical instrumentsutilized in cancer treatment, which employ various sensors andalgorithms for assessing proximity to cancerous tissue and/or assistinga user in navigating a safe distance away from cancerous tissue. Thesurgical instruments can be utilized alone or as components of acomputer-implemented interactive surgical system.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. One or more of the surgicalinstruments of the present disclosure can be implemented as robotictools for use with a robotic system. A robotic system 110 is used in thesurgical procedure as a part of the surgical system 102. The roboticsystem 110 includes a surgeon's console 118, a patient side cart 120(surgical robot), and a surgical robotic hub 122. The patient side cart120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for Health Level-7,picture archive and communication system, and electronic medical record(EMR). Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a monitor 135,an imaging module 138, a generator module 140, a communication module130, a processor module 132, and a storage array 134. In certainaspects, as illustrated in FIG. 3, the hub 106 further includes a smokeevacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar radio frequency (RF) energy generatorcomponent, and a monopolar RF energy generator component that are housedin a single unit. In one aspect, the combo generator module alsoincludes a smoke evacuation component, at least one energy deliverycable for connecting the combo generator module to a surgicalinstrument, at least one smoke evacuation component configured toevacuate smoke, fluid, and/or particulates generated by the applicationof therapeutic energy to the tissue, and a fluid line extending from theremote surgical site to the smoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts.

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

One or more of the monopolar device 146, bipolar device 147, andultrasonic device 148 can be equipped with sensors and algorithms forassessing proximity to cancerous tissue and/or assisting a user innavigating a safe distance away from cancerous tissue, as described ingreater detail below.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128,and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy delivery implement. The energy delivery implement isconfigured to deliver ultrasonic and/or RF energy to the surgical siteand is coupled to the generator module 140 by a cable extendinginitially through the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128, and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a verticalmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, published on Dec. 15, 2011,and U.S. Patent Application Publication No. 2014/0243597, titled SYSTEMFOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, published onAug. 28, 2014, the disclosure of each of which is herein incorporated byreference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices la-1a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 209 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to Wi-Fi (IEEE 802.11 family), WMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, in accordance with at least one aspect of thepresent disclosure. In the illustrated aspect, the USB network hubdevice 300 employs a TUSB2036 integrated circuit hub by TexasInstruments. The USB network hub 300 is a CMOS device that provides anupstream USB transceiver port 302 and up to three downstream USBtransceiver ports 304, 306, 308 in compliance with the USB 2.0specification. The upstream USB transceiver port 302 is a differentialroot data port comprising a differential data minus (DMO) input pairedwith a differential data plus (DPO) input. The three downstream USBtransceiver ports 304, 306, 308 are differential data ports where eachport includes differential data plus (DP1-DP3) outputs paired withdifferential data minus (DM1-DM3) outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware

FIG. 12 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The control system 470 includes amicrocontroller 461 comprising a processor 462 and a memory 468. One ormore of sensors 472, 474, 476, for example, provide real-time feedbackto the processor 462. A motor 482, driven by a motor driver 492,operably couples a longitudinally movable displacement member to drivethe I-beam knife element. A tracking system 480 is configured todetermine the position of the longitudinally movable displacementmember. The position information is provided to the processor 462, whichcan be programmed or configured to determine the position of thelongitudinally movable drive member as well as the position of a firingmember, firing bar, and I-beam knife element. Additional motors may beprovided at the tool driver interface to control I-beam firing, closuretube travel, shaft rotation, and articulation. A display 473 displays avariety of operating conditions of the instruments and may include touchscreen functionality for data input. Information displayed on thedisplay 473 may be overlaid with images acquired via endoscopic imagingmodules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 includes aprocessor 462 and a memory 468. The electric motor 482 may be a brusheddirect current (DC) motor with a gearbox and mechanical links to anarticulation or knife system. In one aspect, a motor driver 492 may bean A3941 available from Allegro Microsystems, Inc. Other motor driversmay be readily substituted for use in the tracking system 480 comprisingan absolute positioning system. A detailed description of an absolutepositioning system is described in U.S. Patent Application PublicationNo. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICALSTAPLING AND CUTTING INSTRUMENT, published on Oct. 19, 2017, which isherein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion (LI) batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10V) gate drive for battery voltages down to 7V andallows the A3941 to operate with a reduced gate drive, down to 5.5V. Abootstrap capacitor may be employed to provide the above battery supplyvoltage required for N-channel MOSFETs. An internal charge pump for thehigh-side drive allows DC (100% duty cycle) operation. The full bridgecan be driven in fast or slow decay modes using diode or synchronousrectification. In the slow decay mode, current recirculation can bethrough the high-side or the lowside FETs. The power FETs are protectedfrom shoot-through by resistor-adjustable dead time. Integrateddiagnostics provide indications of undervoltage, overtemperature, andpower bridge faults and can be configured to protect the power MOSFETsunder most short circuit conditions. Other motor drivers may be readilysubstituted for use in the tracking system 480 comprising an absolutepositioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472, in accordance with atleast one aspect of this disclosure. The position sensor 472 for anabsolute positioning system provides a unique position signalcorresponding to the location of a displacement member. In one aspect,the displacement member represents a longitudinally movable drive membercomprising a rack of drive teeth for meshing engagement with acorresponding drive gear of a gear reducer assembly. In other aspects,the displacement member represents the firing member, which could beadapted and configured to include a rack of drive teeth. In yet anotheraspect, the displacement member represents a firing bar or the I-beam,each of which can be adapted and configured to include a rack of driveteeth. Accordingly, as used herein, the term displacement member is usedgenerically to refer to any movable member of the surgical instrument ortool such as the drive member, the firing member, the firing bar, theI-beam, or any element that can be displaced. In one aspect, thelongitudinally movable drive member is coupled to the firing member, thefiring bar, and the I-beam. Accordingly, the absolute positioning systemcan, in effect, track the linear displacement of the I-beam by trackingthe linear displacement of the longitudinally movable drive member. Invarious other aspects, the displacement member may be coupled to anyposition sensor 472 suitable for measuring linear displacement. Thus,the longitudinally movable drive member, the firing member, the firingbar, or the I-beam, or combinations thereof, may be coupled to anysuitable linear displacement sensor. Linear displacement sensors mayinclude contact or non-contact displacement sensors. Linear displacementsensors may comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall-effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall-effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement dl of theof the displacement member, where dl is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+do ofthe displacement member. The output of the position sensor 472 isprovided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,published on Sep. 18, 2014, which is herein incorporated by reference inits entirety; and U.S. patent application Ser. No. 15/628,175, titledTECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLINGAND CUTTING INSTRUMENT, filed Jun. 20, 2017, which is hereinincorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertial, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to an I-beam in a firingstroke of the surgical instrument or tool. The I-beam is configured toengage a wedge sled, which is configured to upwardly cam staple driversto force out staples into deforming contact with an anvil. The I-beamalso includes a sharpened cutting edge that can be used to sever tissueas the I-beam is advanced distally by the firing bar. Alternatively, acurrent sensor 478 can be employed to measure the current drawn by themotor 482. The force required to advance the firing member cancorrespond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11.

FIG. 13 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool, in accordance with at least oneaspect of this disclosure. The control circuit 500 can be configured toimplement various processes described herein. The control circuit 500may comprise a microcontroller comprising one or more processors 502(e.g., microprocessor, microcontroller) coupled to at least one memorycircuit 504. The memory circuit 504 stores machine-executableinstructions that, when executed by the processor 502, cause theprocessor 502 to execute machine instructions to implement variousprocesses described herein. The processor 502 may be any one of a numberof single-core or multicore processors known in the art. The memorycircuit 504 may comprise volatile and non-volatile storage media. Theprocessor 502 may include an instruction processing unit 506 and anarithmetic unit 508. The instruction processing unit may be configuredto receive instructions from the memory circuit 504 of this disclosure.

FIG. 14 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool, in accordance withat least one aspect of this disclosure. The combinational logic circuit510 can be configured to implement various processes described herein.The combinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of this disclosure. The sequential logic circuit 520 or thecombinational logic 522 can be configured to implement various processesdescribed herein. The sequential logic circuit 520 may comprise a finitestate machine. The sequential logic circuit 520 may comprise acombinational logic 522, at least one memory circuit 524, and a clock529, for example. The at least one memory circuit 524 can store acurrent state of the finite state machine. In certain instances, thesequential logic circuit 520 may be synchronous or asynchronous. Thecombinational logic 522 is configured to receive data associated withthe surgical instrument or tool from an input 526, process the data bythe combinational logic 522, and provide an output 528. In otheraspects, the circuit may comprise a combination of a processor (e.g.,processor 502, FIG. 13) and a finite state machine to implement variousprocesses herein. In other aspects, the finite state machine maycomprise a combination of a combinational logic circuit (e.g.,combinational logic circuit 510, FIG. 14) and the sequential logiccircuit 520.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604, which can be configured to transmitfiring motions, generated by the firing motor 602 to the end effector,in particular to displace the I-beam element. In certain instances, thefiring motions generated by the firing motor 602 may cause the staplesto be deployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the firing motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605, which can be configured to transmitclosure motions, generated by the closure motor 603 to the end effector,in particular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the closure motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The articulationmotors 606 a, 606 b may be operably coupled to respective articulationmotor drive assemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the articulation motors 606 a, 606 bto the end effector. In certain instances, the articulation motions maycause the end effector to articulate relative to the shaft, for example.

As described above, the surgical instrument or tool may include aplurality of motors, which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore, the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610, which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 16, a switch 614 can be moved or transitioned between a pluralityof positions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulation motors 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 16, the common controlmodule 610 may comprise a motor driver 626, which may comprise one ormore H-bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed above.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory 624 may be coupled to the processor 622, forexample.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as an LI battery, for example. In certain instances, thebattery pack may be configured to be releasably mounted to a handle forsupplying power to the surgical instrument 600. A number of batterycells connected in series may be used as the power source 628. Incertain instances, the power source 628 may be replaceable and/orrechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one instance, the processor 622 may be any single-core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In certain instances, the microcontroller 620 may be an LM4F230H5QR, available from Texas Instruments, for example. In at leastone example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4FProcessor Core comprising an on-chip memory of 256 KB single-cycle flashmemory, or other non-volatile memory, up to 40 MHz, a prefetch buffer toimprove performance above 40 MHz, a 32 KB single-cycle SRAM, an internalROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

In certain instances, the memory 624 may include program instructionsfor controlling each of the motors of the surgical instrument 600 thatare couplable to the common control module 610. For example, the memory624 may include program instructions for controlling the firing motor602, the closure motor 603, and the articulation motors 606 a, 606 b.Such program instructions may cause the processor 622 to control thefiring, closure, and articulation functions in accordance with inputsfrom algorithms or control programs of the surgical instrument or tool.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 630 can be employed to alert the processor 622 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 630 may alert the processor 622 to use the programinstructions associated with firing, closing, and articulating the endeffector. In certain instances, the sensors 630 may comprise positionsensors which can be employed to sense the position of the switch 614,for example. Accordingly, the processor 622 may use the programinstructions associated with firing the I-beam of the end effector upondetecting, through the sensors 630 for example, that the switch 614 isin the first position 616; the processor 622 may use the programinstructions associated with closing the anvil upon detecting, throughthe sensors 630 for example, that the switch 614 is in the secondposition 617; and the processor 622 may use the program instructionsassociated with articulating the end effector upon detecting, throughthe sensors 630 for example, that the switch 614 is in the third orfourth position 618 a, 618 b.

FIG. 17 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein, in accordancewith at least one aspect of this disclosure. The robotic surgicalinstrument 700 may be programmed or configured to controldistal/proximal translation of a displacement member, distal/proximaldisplacement of a closure tube, shaft rotation, and articulation, eitherwith single or multiple articulation drive links. In one aspect, thesurgical instrument 700 may be programmed or configured to individuallycontrol a firing member, a closure member, a shaft member, and/or one ormore articulation members. The surgical instrument 700 comprises acontrol circuit 710 configured to control motor-driven firing members,closure members, shaft members, and/or one or more articulation members.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control an anvil 716 and an I-beam 714(including a sharp cutting edge) portion of an end effector 702, aremovable staple cartridge 718, a shaft 740, and one or morearticulation members 742 a, 742 b via a plurality of motors 704 a-704 e.A position sensor 734 may be configured to provide position feedback ofthe I-beam 714 to the control circuit 710. Other sensors 738 may beconfigured to provide feedback to the control circuit 710. Atimer/counter 731 provides timing and counting information to thecontrol circuit 710. An energy source 712 may be provided to operate themotors 704 a-704 e, and a current sensor 736 provides motor currentfeedback to the control circuit 710. The motors 704 a-704 e can beoperated individually by the control circuit 710 in an open-loop orclosed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the I-beam 714 as determined bythe position sensor 734 with the output of the timer/counter 731 suchthat the control circuit 710 can determine the position of the I-beam714 at a specific time (t) relative to a starting position or the time(t) when the I-beam 714 is at a specific position relative to a startingposition. The timer/counter 731 may be configured to measure elapsedtime, count external events, or time external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the anvil 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrols 708 a-708 e. The motor controls 708 a-708 e may comprise one ormore circuits configured to provide motor drive signals to the motors704 a-704 e to drive the motors 704 a-704 e as described herein. In someexamples, the motors 704 a-704 e may be brushed DC electric motors. Forexample, the velocity of the motors 704 a-704 e may be proportional tothe respective motor drive signals. In some examples, the motors 704a-704 e may be brushless DC electric motors, and the respective motordrive signals may comprise a PWM signal provided to one or more statorwindings of the motors 704 a-704 e. Also, in some examples, the motorcontrols 708 a-708 e may be omitted and the control circuit 710 maygenerate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe I-beam 714, anvil 716, shaft 740, articulation 742 a, andarticulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the I-beam 714.The position sensor 734 may be or include any type of sensor that iscapable of generating position data that indicate a position of theI-beam 714. In some examples, the position sensor 734 may include anencoder configured to provide a series of pulses to the control circuit710 as the I-beam 714 translates distally and proximally. The controlcircuit 710 may track the pulses to determine the position of the I-beam714. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 714. Also, in someexamples, the position sensor 734 may be omitted. Where any of themotors 704 a-704 e is a stepper motor, the control circuit 710 may trackthe position of the I-beam 714 by aggregating the number and directionof steps that the motor 704 has been instructed to execute. The positionsensor 734 may be located in the end effector 702 or at any otherportion of the instrument. The outputs of each of the motors 704 a-704 einclude a torque sensor 744 a-744 e to sense force and have an encoderto sense rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the I-beam 714 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 a,which provides a drive signal to the motor 704 a. The output shaft ofthe motor 704 a is coupled to a torque sensor 744 a. The torque sensor744 a is coupled to a transmission 706 a which is coupled to the I-beam714. The transmission 706 a comprises movable mechanical elements suchas rotating elements and a firing member to control the movement of theI-beam 714 distally and proximally along a longitudinal axis of the endeffector 702. In one aspect, the motor 704 a may be coupled to the knifegear assembly, which includes a knife gear reduction set that includes afirst knife drive gear and a second knife drive gear. A torque sensor744 a provides a firing force feedback signal to the control circuit710. The firing force signal represents the force required to fire ordisplace the I-beam 714. A position sensor 734 may be configured toprovide the position of the I-beam 714 along the firing stroke or theposition of the firing member as a feedback signal to the controlcircuit 710. The end effector 702 may include additional sensors 738configured to provide feedback signals to the control circuit 710. Whenready to use, the control circuit 710 may provide a firing signal to themotor control 708 a. In response to the firing signal, the motor 704 amay drive the firing member distally along the longitudinal axis of theend effector 702 from a proximal stroke start position to a stroke endposition distal to the stroke start position. As the firing membertranslates distally, an I-beam 714, with a cutting element positioned ata distal end, advances distally to cut tissue located between the staplecartridge 718 and the anvil 716.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the anvil 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the anvil716. The transmission 706 b comprises movable mechanical elements suchas rotating elements and a closure member to control the movement of theanvil 716 from the open and closed positions. In one aspect, the motor704 b is coupled to a closure gear assembly, which includes a closurereduction gear set that is supported in meshing engagement with theclosure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the anvil 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable anvil716 is positioned opposite the staple cartridge 718. When ready to use,the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the anvil 716 and thestaple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702 ±65°. In one aspect,the motor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack), which are driven by the two motors708 d, 708 e. When the separate firing motor 704 a is provided, each ofthe articulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the staple cartridge 718 deck to determinetissue location using segmented electrodes. The torque sensors 744 a-744e may be configured to sense force such as firing force, closure force,and/or articulation force, among others. Accordingly, the controlcircuit 710 can sense (1) the closure load experienced by the distalclosure tube and its position, (2) the firing member at the rack and itsposition, (3) what portion of the staple cartridge 718 has tissue on it,and (4) the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the anvil 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the anvil 716 and the staple cartridge 718. The sensors 738 maybe configured to detect impedance of a tissue section located betweenthe anvil 716 and the staple cartridge 718 that is indicative of thethickness and/or fullness of tissue located therebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the anvil 716 by the closure drive system. For example, oneor more sensors 738 can be at an interaction point between the closuretube and the anvil 716 to detect the closure forces applied by theclosure tube to the anvil 716. The forces exerted on the anvil 716 canbe representative of the tissue compression experienced by the tissuesection captured between the anvil 716 and the staple cartridge 718. Theone or more sensors 738 can be positioned at various interaction pointsalong the closure drive system to detect the closure forces applied tothe anvil 716 by the closure drive system. The one or more sensors 738may be sampled in real time during a clamping operation by the processorof the control circuit 710. The control circuit 710 receives real-timesample measurements to provide and analyze time-based information andassess, in real time, closure forces applied to the anvil 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the I-beam 714corresponds to the current drawn by one of the motors 704 a-704 e. Theforce is converted to a digital signal and provided to the controlcircuit 710. The control circuit 710 can be configured to simulate theresponse of the actual system of the instrument in the software of thecontroller. A displacement member can be actuated to move an I-beam 714in the end effector 702 at or near a target velocity. The roboticsurgical instrument 700 can include a feedback controller, which can beone of any feedback controllers, including, but not limited to a PID, astate feedback, a linear-quadratic (LQR), and/or an adaptive controller,for example. The robotic surgical instrument 700 can include a powersource to convert the signal from the feedback controller into aphysical input such as case voltage, PWM voltage, frequency modulatedvoltage, current, torque, and/or force, for example. Additional detailsare disclosed in U.S. patent application Ser. No. 15/636,829, titledCLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT,filed Jun. 29, 2017, which is herein incorporated by reference in itsentirety.

FIG. 18 illustrates a block diagram of a surgical instrument 750programmed to control the distal translation of a displacement member,in accordance with at least one aspect of this disclosure. In oneaspect, the surgical instrument 750 is programmed to control the distaltranslation of a displacement member such as the I-beam 764. Thesurgical instrument 750 comprises an end effector 752 that may comprisean anvil 766, an I-beam 764 (including a sharp cutting edge), and aremovable staple cartridge 768.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensor784. Because the I-beam 764 is coupled to a longitudinally movable drivemember, the position of the I-beam 764 can be determined by measuringthe position of the longitudinally movable drive member employing theposition sensor 784. Accordingly, in the following description, theposition, displacement, and/or translation of the I-beam 764 can beachieved by the position sensor 784 as described herein. A controlcircuit 760 may be programmed to control the translation of thedisplacement member, such as the I-beam 764. The control circuit 760, insome examples, may comprise one or more microcontrollers,microprocessors, or other suitable processors for executing instructionsthat cause the processor or processors to control the displacementmember, e.g., the I-beam 764, in the manner described. In one aspect, atimer/counter 781 provides an output signal, such as the elapsed time ora digital count, to the control circuit 760 to correlate the position ofthe I-beam 764 as determined by the position sensor 784 with the outputof the timer/counter 781 such that the control circuit 760 can determinethe position of the I-beam 764 at a specific time (t) relative to astarting position. The timer/counter 781 may be configured to measureelapsed time, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor control 758. Themotor control 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor control 758 may be omitted,and the control circuit 760 may generate the motor drive signal 774directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor 754 has been instructed to execute. The position sensor 784 may belocated in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by a closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor of the control circuit760. The control circuit 760 receives real-time sample measurements toprovide and analyze time-based information and assess, in real time,closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move an I-beam 764 in the endeffector 752 at or near a target velocity. The surgical instrument 750can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or I-beam 764, by abrushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies, and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical stapling andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable anvil 766and, when configured for use, a staple cartridge 768 positioned oppositethe anvil 766. A clinician may grasp tissue between the anvil 766 andthe staple cartridge 768, as described herein. When ready to use thesurgical instrument 750, the clinician may provide a firing signal, forexample by depressing a trigger of the surgical instrument 750. Inresponse to the firing signal, the motor 754 may drive the displacementmember distally along the longitudinal axis of the end effector 752 froma proximal stroke begin position to a stroke end position distal of thestroke begin position. As the displacement member translates distally,an I-beam 764 with a cutting element positioned at a distal end may cutthe tissue between the staple cartridge 768 and the anvil 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the I-beam 764, for example, based on oneor more tissue conditions. The control circuit 760 may be programmed tosense tissue conditions, such as thickness, either directly orindirectly, as described herein. The control circuit 760 may beprogrammed to select a firing control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 760 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of the surgicalinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 19 is a schematic diagram of a surgical instrument 790 configuredto control various functions, in accordance with at least one aspect ofthis disclosure. In one aspect, the surgical instrument 790 isprogrammed to control distal translation of a displacement member suchas the I-beam 764. The surgical instrument 790 comprises an end effector792 that may comprise an anvil 766, an I-beam 764, and a removablestaple cartridge 768, which may be interchanged with an RF cartridge 796(shown in dashed line).

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife membercomprising a knife body that operably supports a tissue cutting bladethereon and may further include anvil engagement tabs or features andchannel engagement features or a foot. In one aspect, the staplecartridge 768 may be implemented as a standard (mechanical) surgicalfastener cartridge. In one aspect, the RF cartridge 796 may beimplemented as an RF cartridge. These and other sensors arrangements aredescribed in commonly owned U.S. patent application Ser. No. 15/628,175,titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICALSTAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, which is hereinincorporated by reference in its entirety.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensorrepresented as position sensor 784. Because the I-beam 764 is coupled tothe longitudinally movable drive member, the position of the I-beam 764can be determined by measuring the position of the longitudinallymovable drive member employing the position sensor 784. Accordingly, inthe following description, the position, displacement, and/ortranslation of the I-beam 764 can be achieved by the position sensor 784as described herein. A control circuit 760 may be programmed to controlthe translation of the displacement member, such as the I-beam 764, asdescribed herein. The control circuit 760, in some examples, maycomprise one or more microcontrollers, microprocessors, or othersuitable processors for executing instructions that cause the processoror processors to control the displacement member, e.g., the I-beam 764,in the manner described. In one aspect, a timer/counter 781 provides anoutput signal, such as the elapsed time or a digital count, to thecontrol circuit 760 to correlate the position of the I-beam 764 asdetermined by the position sensor 784 with the output of thetimer/counter 781 such that the control circuit 760 can determine theposition of the I-beam 764 at a specific time (t) relative to a startingposition. The timer/counter 781 may be configured to measure elapsedtime, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor control 758. Themotor control 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor control 758 may be omitted,and the control circuit 760 may generate the motor drive signal 774directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor has been instructed to execute. The position sensor 784 may belocated in the end effector 792 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by the closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor portion of the controlcircuit 760. The control circuit 760 receives real-time samplemeasurements to provide and analyze time-based information and assess,in real time, closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF cartridge 796 when the RF cartridge 796 is loaded inthe end effector 792 in place of the staple cartridge 768. The controlcircuit 760 controls the delivery of the RF energy to the RF cartridge796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

FIGS. 21 to 24 depict a motor-driven surgical instrument 150010 forcutting and fastening that may or may not be reused. In the illustratedexamples, the surgical instrument 150010 includes a housing 150012 thatcomprises a handle assembly 150014 that is configured to be grasped,manipulated, and actuated by the clinician. The housing 150012 isconfigured for operable attachment to an interchangeable shaft assembly150200 that has an end effector 150300 operably coupled thereto that isconfigured to perform one or more surgical tasks or procedures. Inaccordance with the present disclosure, various forms of interchangeableshaft assemblies may be effectively employed in connection withrobotically controlled surgical systems. The term “housing” mayencompass a housing or similar portion of a robotic system that housesor otherwise operably supports at least one drive system configured togenerate and apply at least one control motion that could be used toactuate interchangeable shaft assemblies. The term “frame” may refer toa portion of a handheld surgical instrument. The term “frame” also mayrepresent a portion of a robotically controlled surgical instrumentand/or a portion of the robotic system that may be used to operablycontrol a surgical instrument. Interchangeable shaft assemblies may beemployed with various robotic systems, instruments, components, andmethods disclosed in U.S. Pat. No. 9,072,535, titled SURGICAL STAPLINGINSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, which isherein incorporated by reference in its entirety.

FIG. 21 is a perspective view of a surgical instrument 150010 that hasan interchangeable shaft assembly 150200 operably coupled thereto, inaccordance with at least one aspect of this disclosure. The housing150012 includes an end effector 150300 that comprises a surgical cuttingand fastening device configured to operably support a surgical staplecartridge 150304 therein. The housing 150012 may be configured for usein connection with interchangeable shaft assemblies that include endeffectors that are adapted to support different sizes and types ofstaple cartridges and have different shaft lengths, sizes, and types.The housing 150012 may be employed with a variety of interchangeableshaft assemblies, including assemblies configured to apply other motionsand forms of energy such as, radio frequency (RF) energy, ultrasonicenergy, and/or motion to end effector arrangements adapted for use inconnection with various surgical applications and procedures. The endeffectors, shaft assemblies, handles, surgical instruments, and/orsurgical instrument systems can utilize any suitable fastener, orfasteners, to fasten tissue. For instance, a fastener cartridgecomprising a plurality of fasteners removably stored therein can beremovably inserted into and/or attached to the end effector of a shaftassembly.

The handle assembly 150014 may comprise a pair of interconnectablehandle housing segments 150016, 150018 interconnected by screws, snapfeatures, adhesive, etc. The handle housing segments 150016, 150018cooperate to form a pistol grip portion 150019 that can be gripped andmanipulated by the clinician. The handle assembly 150014 operablysupports a plurality of drive systems configured to generate and applycontrol motions to corresponding portions of the interchangeable shaftassembly that is operably attached thereto. A display may be providedbelow a cover 150045.

FIG. 22 is an exploded assembly view of a portion of the surgicalinstrument 150010 of FIG. 21, in accordance with at least one aspect ofthis disclosure. The handle assembly 150014 may include a frame 150020that operably supports a plurality of drive systems. The frame 150020can operably support a “first” or closure drive system 150030, which canapply closing and opening motions to the interchangeable shaft assembly150200. The closure drive system 150030 may include an actuator such asa closure trigger 150032 pivotally supported by the frame 150020. Theclosure trigger 150032 is pivotally coupled to the handle assembly150014 by a pivot pin 150033 to enable the closure trigger 150032 to bemanipulated by a clinician. When the clinician grips the pistol gripportion 150019 of the handle assembly 150014, the closure trigger 150032can pivot from a starting or “unactuated” position to an “actuated”position and more particularly to a fully compressed or fully actuatedposition.

The handle assembly 150014 and the frame 150020 may operably support afiring drive system 150080 configured to apply firing motions tocorresponding portions of the interchangeable shaft assembly attachedthereto. The firing drive system 150080 may employ an electric motor150082 located in the pistol grip portion 150019 of the handle assembly150014. The electric motor 150082 may be a DC brushed motor having amaximum rotational speed of approximately 25,000 RPM, for example. Inother arrangements, the motor may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The electric motor 150082 may be powered by a powersource 150090 that may comprise a removable power pack 150092. Theremovable power pack 150092 may comprise a proximal housing portion150094 configured to attach to a distal housing portion 150096. Theproximal housing portion 150094 and the distal housing portion 150096are configured to operably support a plurality of batteries 150098therein. Batteries 150098 may each comprise, for example, an LI or othersuitable battery. The distal housing portion 150096 is configured forremovable operable attachment to a control circuit board 150100, whichis operably coupled to the electric motor 150082. Several batteries150098 connected in series may power the surgical instrument 150010. Thepower source 150090 may be replaceable and/or rechargeable. A display150043, which is located below the cover 150045, is electrically coupledto the control circuit board 150100. The cover 150045 may be removed toexpose the display 150043.

The electric motor 150082 can include a rotatable shaft (not shown) thatoperably interfaces with a gear reducer assembly 150084 mounted inmeshing engagement with a set, or rack, of drive teeth 150122 on alongitudinally movable drive member 150120. The longitudinally movabledrive member 150120 has a rack of drive teeth 150122 formed thereon formeshing engagement with a corresponding drive gear 150086 of the gearreducer assembly 150084.

In use, a voltage polarity provided by the power source 150090 canoperate the electric motor 150082 in a clockwise direction wherein thevoltage polarity applied to the electric motor by the battery can bereversed in order to operate the electric motor 150082 in acounter-clockwise direction. When the electric motor 150082 is rotatedin one direction, the longitudinally movable drive member 150120 will beaxially driven in the distal direction “DD.” When the electric motor150082 is driven in the opposite rotary direction, the longitudinallymovable drive member 150120 will be axially driven in a proximaldirection “PD.” The handle assembly 150014 can include a switch that canbe configured to reverse the polarity applied to the electric motor150082 by the power source 150090. The handle assembly 150014 mayinclude a sensor configured to detect the position of the longitudinallymovable drive member 150120 and/or the direction in which thelongitudinally movable drive member 150120 is being moved.

Actuation of the electric motor 150082 can be controlled by a firingtrigger 150130 that is pivotally supported on the handle assembly150014. The firing trigger 150130 may be pivoted between an unactuatedposition and an actuated position.

Turning back to FIG. 21, the interchangeable shaft assembly 150200includes an end effector 150300 comprising an elongated channel 150302configured to operably support a surgical staple cartridge 150304therein. The end effector 150300 may include an anvil 150306 that ispivotally supported relative to the elongated channel 150302. Theinterchangeable shaft assembly 150200 may include an articulation joint150270. Construction and operation of the end effector 150300 and thearticulation joint 150270 are set forth in U.S. Patent ApplicationPublication No. 2014/0263541, titled ARTICULATABLE SURGICAL INSTRUMENTCOMPRISING AN ARTICULATION LOCK, which is herein incorporated byreference in its entirety. The interchangeable shaft assembly 150200 mayinclude a proximal housing or nozzle 150201 comprised of nozzle portions150202, 150203. The interchangeable shaft assembly 150200 may include aclosure tube 150260 extending along a shaft axis “SA” that can beutilized to close and/or open the anvil 150306 of the end effector150300.

Turning back to FIG. 21, the closure tube 150260 is translated distally(direction “DD”) to close the anvil 150306, for example, in response tothe actuation of the closure trigger 150032 in the manner described inthe aforementioned reference U.S. Patent Application Publication No.2014/0263541. The anvil 150306 is opened by proximally translating theclosure tube 150260. In the anvil-open position, the closure tube 150260is moved to its proximal position.

FIG. 23 is another exploded assembly view of portions of theinterchangeable shaft assembly 150200, in accordance with at least oneaspect of this disclosure. The interchangeable shaft assembly 150200 mayinclude a firing member 150220 supported for axial travel within thespine 150210. The firing member 150220 includes an intermediate firingshaft 150222 configured to attach to a distal cutting portion or knifebar 150280. The firing member 150220 may be referred to as a “secondshaft” or a “second shaft assembly.” The intermediate firing shaft150222 may include a longitudinal slot 150223 in a distal end configuredto receive a tab 150284 on the proximal end 150282 of the knife bar150280. The longitudinal slot 150223 and the proximal end 150282 may beconfigured to permit relative movement there between and can comprise aslip joint 150286. The slip joint 150286 can permit the intermediatefiring shaft 150222 of the firing member 150220 to articulate the endeffector 150300 about the articulation joint 150270 without moving, orat least substantially moving, the knife bar 150280. Once the endeffector 150300 has been suitably oriented, the intermediate firingshaft 150222 can be advanced distally until a proximal sidewall of thelongitudinal slot 150223 contacts the tab 150284 to advance the knifebar 150280 and fire the staple cartridge positioned within the channel150302. The spine 150210 has an elongated opening or window 150213therein to facilitate assembly and insertion of the intermediate firingshaft 150222 into the spine 150210. Once the intermediate firing shaft150222 has been inserted therein, a top frame segment 150215 may beengaged with the shaft frame 150212 to enclose the intermediate firingshaft 150222 and knife bar 150280 therein. Operation of the firingmember 150220 may be found in U.S. Patent Application Publication No.2014/0263541. A spine 150210 can be configured to slidably support afiring member 150220 and the closure tube 150260 that extends around thespine 150210. The spine 150210 may slidably support an articulationdriver 150230.

The interchangeable shaft assembly 150200 can include a clutch assembly150400 configured to selectively and releasably couple the articulationdriver 150230 to the firing member 150220. The clutch assembly 150400includes a lock collar, or lock sleeve 150402, positioned around thefiring member 150220 wherein the lock sleeve 150402 can be rotatedbetween an engaged position in which the lock sleeve 150402 couples thearticulation driver 150230 to the firing member 150220 and a disengagedposition in which the articulation driver 150230 is not operably coupledto the firing member 150220. When the lock sleeve 150402 is in theengaged position, distal movement of the firing member 150220 can movethe articulation driver 150230 distally and, correspondingly, proximalmovement of the firing member 150220 can move the articulation driver150230 proximally. When the lock sleeve 150402 is in the disengagedposition, movement of the firing member 150220 is not transmitted to thearticulation driver 150230 and, as a result, the firing member 150220can move independently of the articulation driver 150230. The nozzle150201 may be employed to operably engage and disengage the articulationdrive system with the firing drive system in the various mannersdescribed in U.S. Patent Application Publication No. 2014/0263541.

The interchangeable shaft assembly 150200 can comprise a slip ringassembly 150600, which can be configured to conduct electrical power toand/or from the end effector 150300 and/or communicate signals to and/orfrom the end effector 150300, for example. The slip ring assembly 150600can comprise a proximal connector flange 150604 and a distal connectorflange 150601 positioned within a slot defined in the nozzle portions150202, 150203. The proximal connector flange 150604 can comprise afirst face and the distal connector flange 150601 can comprise a secondface positioned adjacent to and movable relative to the first face. Thedistal connector flange 150601 can rotate relative to the proximalconnector flange 150604 about the shaft axis “SA” (FIG. 21). Theproximal connector flange 150604 can comprise a plurality of concentric,or at least substantially concentric, conductors 150602 defined in thefirst face thereof. A connector 150607 can be mounted on the proximalside of the distal connector flange 150601 and may have a plurality ofcontacts wherein each contact corresponds to and is in electricalcontact with one of the conductors 150602. Such an arrangement permitsrelative rotation between the proximal connector flange 150604 and thedistal connector flange 150601 while maintaining electrical contactthere between. The proximal connector flange 150604 can include anelectrical connector 150606 that can place the conductors 150602 insignal communication with a shaft circuit board, for example. In atleast one instance, a wiring harness comprising a plurality ofconductors can extend between the electrical connector 150606 and theshaft circuit board. The electrical connector 150606 may extendproximally through a connector opening defined in the chassis mountingflange. U.S. Patent Application Publication No. 2014/0263551, titledSTAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, is incorporated hereinby reference in its entirety. U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, isincorporated by reference in its entirety. Further details regardingslip ring assembly 150600 may be found in U.S. Patent ApplicationPublication No. 2014/0263541.

The interchangeable shaft assembly 150200 can include a proximal portionfixably mounted to the handle assembly 150014 and a distal portion thatis rotatable about a longitudinal axis. The rotatable distal shaftportion can be rotated relative to the proximal portion about the slipring assembly 150600. The distal connector flange 150601 of the slipring assembly 150600 can be positioned within the rotatable distal shaftportion.

FIG. 24 is an exploded view of one aspect of an end effector 150300 ofthe surgical instrument 150010 of FIG. 21, in accordance with at leastone aspect of this disclosure. The end effector 150300 may include theanvil 150306 and the surgical staple cartridge 150304. The anvil 150306may be coupled to an elongated channel 150302. Apertures 150199 can bedefined in the elongated channel 150302 to receive pins 150152 extendingfrom the anvil 150306 to allow the anvil 150306 to pivot from an openposition to a closed position relative to the elongated channel 150302and surgical staple cartridge 150304. A firing bar 150172 is configuredto longitudinally translate into the end effector 150300. The firing bar150172 may be constructed from one solid section, or may include alaminate material comprising a stack of steel plates. The firing bar150172 comprises an I-beam 150178 and a cutting edge 150182 at a distalend thereof. A distally projecting end of the firing bar 150172 can beattached to the I-beam 150178 to assist in spacing the anvil 150306 froma surgical staple cartridge 150304 positioned in the elongated channel150302 when the anvil 150306 is in a closed position. The I-beam 150178may include a sharpened cutting edge 150182 to sever tissue as theI-beam 150178 is advanced distally by the firing bar 150172. Inoperation, the I-beam 150178 may, or fire, the surgical staple cartridge150304. The surgical staple cartridge 150304 can include a moldedcartridge body 150194 that holds a plurality of staples 150191 restingupon staple drivers 150192 within respective upwardly open staplecavities 150195. A wedge sled 150190 is driven distally by the I-beam150178, sliding upon a cartridge tray 150196 of the surgical staplecartridge 150304. The wedge sled 150190 upwardly cams the staple drivers150192 to force out the staples 150191 into deforming contact with theanvil 150306 while the cutting edge 150182 of the I-beam 150178 seversclamped tissue.

The I-beam 150178 can include upper pins 150180 that engage the anvil150306 during firing. The I-beam 150178 may include middle pins 150184and a bottom foot 150186 to engage portions of the cartridge body150194, cartridge tray 150196, and elongated channel 150302. When asurgical staple cartridge 150304 is positioned within the elongatedchannel 150302, a slot 150193 defined in the cartridge body 150194 canbe aligned with a longitudinal slot 150197 defined in the cartridge tray150196 and a slot 150189 defined in the elongated channel 150302. Inuse, the I-beam 150178 can slide through the aligned longitudinal slots150193, 150197, and 150189 wherein, as indicated in FIG. 24, the bottomfoot 150186 of the I-beam 150178 can engage a groove running along thebottom surface of elongated channel 150302 along the length of slot150189, the middle pins 150184 can engage the top surfaces of cartridgetray 150196 along the length of longitudinal slot 150197, and the upperpins 150180 can engage the anvil 150306. The I-beam 150178 can space, orlimit the relative movement between, the anvil 150306 and the surgicalstaple cartridge 150304 as the firing bar 150172 is advanced distally tofire the staples from the surgical staple cartridge 150304 and/or incisethe tissue captured between the anvil 150306 and the surgical staplecartridge 150304. The firing bar 150172 and the I-beam 150178 can beretracted proximally allowing the anvil 150306 to be opened to releasethe two stapled and severed tissue portions.

FIGS. 25A and 25B is a block diagram of a control circuit 150700 of thesurgical instrument 150010 of FIG. 21 spanning two drawing sheets, inaccordance with at least one aspect of this disclosure. Referringprimarily to FIGS. 25A and 25B, a handle assembly 150702 may include amotor 150714, which can be controlled by a motor driver 150715 and canbe employed by the firing system of the surgical instrument 150010. Invarious forms, the motor 150714 may be a DC brushed driving motor havinga maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 150714 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 150715 may comprise an H-bridge drivercomprising FETs 150719, for example. The motor 150714 can be powered bythe power assembly 150706 releasably mounted to the handle assembly150200 for supplying control power to the surgical instrument 150010.The power assembly 150706 may comprise a battery which may include anumber of battery cells connected in series that can be used as thepower source to power the surgical instrument 150010. In certaincircumstances, the battery cells of the power assembly 150706 may bereplaceable and/or rechargeable. In at least one example, the batterycells can be LI batteries which can be separably couplable to the powerassembly 150706.

The shaft assembly 150704 may include a shaft assembly controller150722, which can communicate with a safety controller and powermanagement controller 150716 through an interface while the shaftassembly 150704 and the power assembly 150706 are coupled to the handleassembly 150702. For example, the interface may comprise a firstinterface portion 150725, which may include one or more electricconnectors for coupling engagement with corresponding shaft assemblyelectric connectors, and a second interface portion 150727, which mayinclude one or more electric connectors for coupling engagement withcorresponding power assembly electric connectors to permit electricalcommunication between the shaft assembly controller 150722 and the powermanagement controller 150716 while the shaft assembly 150704 and thepower assembly 150706 are coupled to the handle assembly 150702. One ormore communication signals can be transmitted through the interface tocommunicate one or more of the power requirements of the attachedinterchangeable shaft assembly 150704 to the power management controller150716. In response, the power management controller may modulate thepower output of the battery of the power assembly 150706, as describedbelow in greater detail, in accordance with the power requirements ofthe attached shaft assembly 150704. The connectors may comprise switcheswhich can be activated after mechanical coupling engagement of thehandle assembly 150702 to the shaft assembly 150704 and/or to the powerassembly 150706 to allow electrical communication between the shaftassembly controller 150722 and the power management controller 150716.

The interface can facilitate transmission of the one or morecommunication signals between the power management controller 150716 andthe shaft assembly controller 150722 by routing such communicationsignals through a main controller 150717 residing in the handle assembly150702, for example. In other circumstances, the interface canfacilitate a direct line of communication between the power managementcontroller 150716 and the shaft assembly controller 150722 through thehandle assembly 150702 while the shaft assembly 150704 and the powerassembly 150706 are coupled to the handle assembly 150702.

The main controller 150717 may be any single core or multicore processorsuch as those known under the trade name ARM Cortex by TexasInstruments. In one aspect, the main controller 150717 may be anLM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle serial random access memory (SRAM), internal read-onlymemory (ROM) loaded with StellarisWare® software, 2 KB electricallyerasable programmable read-only memory (EEPROM), one or more pulse widthmodulation (PWM) modules, one or more quadrature encoder inputs (QEI)analog, one or more 12-bit Analog-to-Digital Converters (ADC) with 12analog input channels, details of which are available for the productdatasheet.

The safety controller may be a safety controller platform comprising twocontroller-based families such as TMS570 and RM4x known under the tradename Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

The power assembly 150706 may include a power management circuit whichmay comprise the power management controller 150716, a power modulator150738, and a current sense circuit 150736. The power management circuitcan be configured to modulate power output of the battery based on thepower requirements of the shaft assembly 150704 while the shaft assembly150704 and the power assembly 150706 are coupled to the handle assembly150702. The power management controller 150716 can be programmed tocontrol the power modulator 150738 of the power output of the powerassembly 150706 and the current sense circuit 150736 can be employed tomonitor power output of the power assembly 150706 to provide feedback tothe power management controller 150716 about the power output of thebattery so that the power management controller 150716 may adjust thepower output of the power assembly 150706 to maintain a desired output.The power management controller 150716 and/or the shaft assemblycontroller 150722 each may comprise one or more processors and/or memoryunits that may store a number of software modules.

The surgical instrument 150010 (FIGS. 21 to 24) may comprise an outputdevice 150742, which may include devices for providing a sensoryfeedback to a user. Such devices may comprise, for example, visualfeedback devices (e.g., a liquid-crystal display (LCD) screen, LEDindicators), audio feedback devices (e.g., a speaker, a buzzer) ortactile feedback devices (e.g., haptic actuators). In certaincircumstances, the output device 150742 may comprise a display 150743,which may be included in the handle assembly 150702. The shaft assemblycontroller 150722 and/or the power management controller 150716 canprovide feedback to a user of the surgical instrument 150010 through theoutput device 150742. The interface can be configured to connect theshaft assembly controller 150722 and/or the power management controller150716 to the output device 150742. The output device 150742 can insteadbe integrated with the power assembly 150706. In such circumstances,communication between the output device 150742 and the shaft assemblycontroller 150722 may be accomplished through the interface while theshaft assembly 150704 is coupled to the handle assembly 150702.

The control circuit 150700 comprises circuit segments configured tocontrol operations of the powered surgical instrument 150010. A safetycontroller segment (Segment 1) comprises a safety controller and themain controller 150717 segment (Segment 2). The safety controller and/orthe main controller 150717 are configured to interact with one or moreadditional circuit segments such as an acceleration segment, a displaysegment, a shaft segment, an encoder segment, a motor segment, and apower segment. Each of the circuit segments may be coupled to the safetycontroller and/or the main controller 150717. The main controller 150717is also coupled to a flash memory. The main controller 150717 alsocomprises a serial communication interface. The main controller 150717comprises a plurality of inputs coupled to, for example, one or morecircuit segments, a battery, and/or a plurality of switches. Thesegmented circuit may be implemented by any suitable circuit, such as,for example, a printed circuit board assembly (PCBA) within the poweredsurgical instrument 150010. It should be understood that the termprocessor as used herein includes any microprocessor, processors,controller, controllers, or other basic computing device thatincorporates the functions of a computer's central processing unit (CPU)on an integrated circuit or at most a few integrated circuits. The maincontroller 150717 is a multipurpose, programmable device that acceptsdigital data as input, processes it according to instructions stored inits memory, and provides results as output. It is an example ofsequential digital logic, as it has internal memory. The control circuit150700 can be configured to implement one or more of the processesdescribed herein.

The acceleration segment (Segment 3) comprises an accelerometer. Theaccelerometer is configured to detect movement or acceleration of thepowered surgical instrument 150010. Input from the accelerometer may beused to transition to and from a sleep mode, identify an orientation ofthe powered surgical instrument, and/or identify when the surgicalinstrument has been dropped. In some examples, the acceleration segmentis coupled to the safety controller and/or the main controller 150717.

The display segment (Segment 4) comprises a display connector coupled tothe main controller 150717. The display connector couples the maincontroller 150717 to a display through one or more integrated circuitdrivers of the display. The integrated circuit drivers of the displaymay be integrated with the display and/or may be located separately fromthe display. The display may comprise any suitable display, such as, forexample, an organic light-emitting diode (OLED) display, aliquid-crystal display (LCD), and/or any other suitable display. In someexamples, the display segment is coupled to the safety controller.

The shaft segment (Segment 5) comprises controls for an interchangeableshaft assembly 150200 (FIGS. 21 and 23) coupled to the surgicalinstrument 150010 (FIGS. 21 to 24) and/or one or more controls for anend effector 150300 coupled to the interchangeable shaft assembly150200. The shaft segment comprises a shaft connector configured tocouple the main controller 150717 to a shaft PCBA. The shaft PCBAcomprises a low-power microcontroller with a ferroelectric random accessmemory (FRAM), an articulation switch, a shaft release Hall effectswitch, and a shaft PCBA EEPROM. The shaft PCBA EEPROM comprises one ormore parameters, routines, and/or programs specific to theinterchangeable shaft assembly 150200 and/or the shaft PCBA. The shaftPCBA may be coupled to the interchangeable shaft assembly 150200 and/orintegral with the surgical instrument 150010. In some examples, theshaft segment comprises a second shaft EEPROM. The second shaft EEPROMcomprises a plurality of algorithms, routines, parameters, and/or otherdata corresponding to one or more shaft assemblies 150200 and/or endeffectors 150300 that may be interfaced with the powered surgicalinstrument 150010.

The position encoder segment (Segment 6) comprises one or more magneticangle rotary position encoders. The one or more magnetic angle rotaryposition encoders are configured to identify the rotational position ofthe motor 150714, an interchangeable shaft assembly 150200 (FIGS. 21 and23), and/or an end effector 150300 of the surgical instrument 150010(FIGS. 21 to 24). In some examples, the magnetic angle rotary positionencoders may be coupled to the safety controller and/or the maincontroller 150717.

The motor circuit segment (Segment 7) comprises a motor 150714configured to control movements of the powered surgical instrument150010 (FIGS. 21 to 24). The motor 150714 is coupled to the mainmicrocontroller processor 150717 by an H-bridge driver comprising one ormore H-bridge field-effect transistors (FETs) and a motor controller.The H-bridge driver is also coupled to the safety controller. A motorcurrent sensor is coupled in series with the motor to measure thecurrent draw of the motor. The motor current sensor is in signalcommunication with the main controller 150717 and/or the safetycontroller. In some examples, the motor 150714 is coupled to a motorelectromagnetic interference (EMI) filter.

The motor controller controls a first motor flag and a second motor flagto indicate the status and position of the motor 150714 to the maincontroller 150717. The main controller 150717 provides a pulse-widthmodulation (PWM) high signal, a PWM low signal, a direction signal, asynchronize signal, and a motor reset signal to the motor controllerthrough a buffer. The power segment is configured to provide a segmentvoltage to each of the circuit segments.

The power segment (Segment 8) comprises a battery coupled to the safetycontroller, the main controller 150717, and additional circuit segments.The battery is coupled to the segmented circuit by a battery connectorand a current sensor. The current sensor is configured to measure thetotal current draw of the segmented circuit. In some examples, one ormore voltage converters are configured to provide predetermined voltagevalues to one or more circuit segments. For example, in some examples,the segmented circuit may comprise 3.3V voltage converters and/or 5Vvoltage converters. A boost converter is configured to provide a boostvoltage up to a predetermined amount, such as, for example, up to 13V.The boost converter is configured to provide additional voltage and/orcurrent during power intensive operations and prevent brownout orlow-power conditions.

A plurality of switches are coupled to the safety controller and/or themain controller 150717. The switches may be configured to controloperations of the surgical instrument 150010 (FIGS. 21 to 24), of thesegmented circuit, and/or indicate a status of the surgical instrument150010. A bail-out door switch and Hall effect switch for bailout areconfigured to indicate the status of a bail-out door. A plurality ofarticulation switches, such as, for example, a left side articulationleft switch, a left side articulation right switch, a left sidearticulation center switch, a right side articulation left switch, aright side articulation right switch, and a right side articulationcenter switch are configured to control articulation of aninterchangeable shaft assembly 150200 (FIGS. 21 and 23) and/or the endeffector 150300 (FIGS. 21 to 24). A left side reverse switch and a rightside reverse switch are coupled to the main controller 150717. The leftside switches comprising the left side articulation left switch, theleft side articulation right switch, the left side articulation centerswitch, and the left side reverse switch are coupled to the maincontroller 150717 by a left flex connector. The right side switchescomprising the right side articulation left switch, the right sidearticulation right switch, the right side articulation center switch,and the right side reverse switch are coupled to the main controller150717 by a right flex connector. A firing switch, a clamp releaseswitch, and a shaft engaged switch are coupled to the main controller150717.

Any suitable mechanical, electromechanical, or solid state switches maybe employed to implement the plurality of switches, in any combination.For example, the switches may be limit switches operated by the motionof components associated with the surgical instrument 150010 (FIGS. 21to 24) or the presence of an object. Such switches may be employed tocontrol various functions associated with the surgical instrument150010. A limit switch is an electromechanical device that consists ofan actuator mechanically linked to a set of contacts. When an objectcomes into contact with the actuator, the device operates the contactsto make or break an electrical connection. Limit switches are used in avariety of applications and environments because of their ruggedness,ease of installation, and reliability of operation. They can determinethe presence or absence, passing, positioning, and end of travel of anobject. In other implementations, the switches may be solid stateswitches that operate under the influence of a magnetic field such asHall-effect devices, magneto-resistive (MR) devices, giantmagneto-resistive (GMR) devices, magnetometers, among others. In otherimplementations, the switches may be solid state switches that operateunder the influence of light, such as optical sensors, infrared sensors,ultraviolet sensors, among others. Still, the switches may be solidstate devices such as transistors (e.g., FET, Junction-FET, metal-oxidesemiconductor-FET (MOSFET), bipolar, and the like). Other switches mayinclude wireless switches, ultrasonic switches, accelerometers, inertialsensors, among others.

FIG. 26 is another block diagram of the control circuit 150700 of thesurgical instrument of FIG. 21 illustrating interfaces between thehandle assembly 150702 and the power assembly 150706 and between thehandle assembly 150702 and the interchangeable shaft assembly 150704, inaccordance with at least one aspect of this disclosure. The handleassembly 150702 may comprise a main controller 150717, a shaft assemblyconnector 150726, and a power assembly connector 150730. The powerassembly 150706 may include a power assembly connector 150732, a powermanagement circuit 150734 that may comprise the power managementcontroller 150716, a power modulator 150738, and a current sense circuit150736. The shaft assembly connectors 150726, 150728 form an interface150727. The power management circuit 150734 can be configured tomodulate power output of the battery 150707 based on the powerrequirements of the interchangeable shaft assembly 150704 while theinterchangeable shaft assembly 150704 and the power assembly 150706 arecoupled to the handle assembly 150702. The power management controller150716 can be programmed to control the power modulator 150738 of thepower output of the power assembly 150706 and the current sense circuit150736 can be employed to monitor power output of the power assembly150706 to provide feedback to the power management controller 150716about the power output of the battery 150707 so that the powermanagement controller 150716 may adjust the power output of the powerassembly 150706 to maintain a desired output. The shaft assembly 150704comprises a shaft processor 150720 coupled to a non-volatile memory150721 and shaft assembly connector 150728 to electrically couple theshaft assembly 150704 to the handle assembly 150702. The shaft assemblyconnectors 150726, 150728 form interface 150725. The main controller150717, the shaft processor 150720, and/or the power managementcontroller 150716 can be configured to implement one or more of theprocesses described herein.

The surgical instrument 150010 (FIGS. 21 to 24) may comprise an outputdevice 150742 to a sensory feedback to a user. Such devices may comprisevisual feedback devices (e.g., an LCD display screen, LED indicators),audio feedback devices (e.g., a speaker, a buzzer), or tactile feedbackdevices (e.g., haptic actuators). In certain circumstances, the outputdevice 150742 may comprise a display 150743 that may be included in thehandle assembly 150702. The shaft assembly controller 150722 and/or thepower management controller 150716 can provide feedback to a user of thesurgical instrument 150010 through the output device 150742. Theinterface 150727 can be configured to connect the shaft assemblycontroller 150722 and/or the power management controller 150716 to theoutput device 150742. The output device 150742 can be integrated withthe power assembly 150706. Communication between the output device150742 and the shaft assembly controller 150722 may be accomplishedthrough the interface 150725 while the interchangeable shaft assembly150704 is coupled to the handle assembly 150702.

Cancerous Tissue Proximity Detection

Cancer is a disease at the cellular level involving disorders incellular control mechanisms. Tumor cells alter their metabolism tomaintain unregulated cellular proliferation and survival, but thistransformation leaves them reliant on constant supply of nutrients andenergy. Cancer cells are shown to experience characteristic changes intheir metabolic programs, including increased uptake of glucose. Manycancer cells have shown an increase in glycolysis (anaerobic metabolism)leading to decreased glucose and increased lactic acid in theinterstitial fluid environment. Accordingly, glucose levels in normaltissue are higher than cancerous tissue. Also, due to the increase inlactic acid levels in cancerous tissue, cancerous tissue pH (potentialof hydrogen) is lower than normal tissue pH.

One of the popular treatments of cancer is to excise the canceroustissue. As illustrated in FIG. 27, a surgical instrument can be employedto seal and cut tissue along a perimeter defined in healthy tissuearound the cancerous tissue. The sealing of the tissue can be achievedby application of energy (e.g., RF or ultrasonic) or by deployment ofstaples into the tissue. In a successful procedure, no cancer cells aredetected at the outer edge of the tissue that was removed, which isreferred to as a clear surgical margin.

Using various existing techniques, a surgeon may attempt to visuallydetermine where tissue grasped by a surgical end effector is locatedrelative to a desired clear surgical margin. Needless to say, suchvisual determination may be inefficient. Furthermore, unintentionallydisturbing the cancerous tissue by cutting through the cancerous tissuemay have undesirable consequences. For example, cancerous cellsdislodged by this process may migrate into other healthy tissue throughthe blood stream, for example, causing the cancer to spread to otherhealthy tissue.

Aspects of the present disclosure present various surgical instrumentsutilized in cancer treatment, which employ various sensors andalgorithms for assessing proximity to cancerous tissue and/or assistinga user in navigating a safe distance away from cancerous tissue beforeapplication of a cancer treatment by the end effector.

FIG. 29 is a logic flow diagram of a process 26120 depicting a controlprogram or a logic configuration for assessing proximity of an endeffector 26000 of a surgical instrument 26010 to cancerous tissue, inaccordance with at least one aspect of the present disclosure. In oneaspect, as described in greater detail below, the process 26120 isexecuted by a control circuit 500 (FIG. 13). In another aspect, theprocess 26120 can be executed by a combinational logic circuit 510 (FIG.14). In yet another aspect, the process 26120 can be executed by asequential logic circuit 520 (FIG. 15).

The process 26120 measures 26123 a physiological parameter of tissue incontact with the end effector 26000, the measured physiologicalparameter being one that indicates proximity of the end effector 26000to cancerous tissue. The process 26120 further alerts 26125 a userand/or overrides 26126 a tissue treatment, if it is determined that thephysiological parameter reaches or crosses a predetermined threshold.

FIG. 30 is a logic flow diagram of a process 26020 depicting a controlprogram or a logic configuration for assessing proximity of an endeffector 26000 of a surgical instrument 26010 to cancerous tissue, inaccordance with at least one aspect of the present disclosure. In oneaspect, as described in greater detail below, the process 26020 isexecuted by a control circuit 500 (FIG. 13). In another aspect, theprocess 26020 can be executed by a combinational logic circuit 510 (FIG.14). In yet another aspect, the process 26020 can be executed by asequential logic circuit 520 (FIG. 15).

The end effector 26000, as illustrated in FIGS. 31 and 32, includes asensor array 26471 configured to generate or provide sensor signalsindicative of a physiological parameter of the tissue that representsproximity of the end effector to cancerous tissue. FIG. 32 illustrates acontrol system 26470 including a control circuit coupled to the sensorarray 26471. The control system 26470 is configured to assess proximityof the end effector 26000 to cancerous tissue based on the sensorsignals of the sensor array 26471.

In one aspect, the physiological parameter is glucose level within thetissue. A low glucose level indicates a close proximity of the endeffector to cancerous tissue.

In another aspect, the physiological parameter is a pH level. A low pHlevel indicates a close proximity of the end effector to canceroustissue.

FIG. 28 is a graph illustrating a physiological parameter of tissue(Y-axis) plotted against distance from a tumor (x-axis). In the exampleof FIG. 28, the physiological parameter decreases with an increase inproximity to the tumor. Examples of physiological parameters thatexhibit such characteristic include glucose, and pH, as described belowin greater detail. Other examples may involve a physiological parameterthat increases with an increase in proximity to the tumor.

In the example of FIG. 28, the physiological parameter of the tissuereaches a normal level (N) at a distance (d) from the tumor, whichdefines a clear margin, as illustrated in FIG. 27. The normal level (N)represents a typical level of the physiological parameter in normaltissue.

The surgical instrument 26010 is similar in many respects to thesurgical instrument 150010. For example, the end effector 26000 andcontrol system 26470 are similar in many respects to the end effector150300 and the control system 470 (FIG. 12), respectively. Forconciseness, components of the surgical instrument 26010 that aresimilar to above-described components of the surgical instrument 150010are not repeated herein in detail.

The end effector 26000 includes a first jaw 26001 and a second jaw 26002extending from an interchangeable shaft assembly 150200. The endeffector 26000 further includes an anvil 26009 (FIG. 32) defined in thefirst jaw 26001 and a staple cartridge 26005 defined in the second jaw26002. At least one of the first jaw 26001 and the second jaw 26002 ismovable relative to the other to transition the end effector 26000between an open configuration and a closed configuration to grasp tissuebetween the anvil 26009 and the staple cartridge 26005. In operation, atissue treatment by the surgical instrument 26010 involves deployingstaples from the staple cartridge 26005 by a firing member 26011 intothe grasped tissue. The deployed staples are deformed by the anvil26009.

In various aspects, a surgical instrument, in accordance with thepresent disclosure, may include an end effector that treats tissue byapplication of RF or ultrasonic energy to tissue. In various aspects,the surgical instrument 26010 can be a handheld surgical instrument.Alternatively, the surgical instrument 26010 can be incorporated into arobotic system as a component of a robotic arm. Additional details onrobotic systems are disclosed in U.S. Provisional Patent Application No.62/611,339, filed Dec. 28, 2017, which is incorporated herein byreference in its entirety.

Measuring the physiological parameter and assessing proximity of the endeffector 26000 to cancerous tissue may begin with activation of thesurgical instrument 26010 and can be continually performed as long asthe surgical instrument 26010 remains operational. Alternatively, asdescribed in connection with the process 26020, such activities can betriggered by, for example, detecting a tissue grasped by the endeffector 26000. In certain instances, such activities can be triggeredreaching or approaching a closed configuration.

The process 26020 detects 26021 whether tissue is grasped by a surgicalend effector 26000. FIG. 20 illustrates an example of a tissue contactcircuit that includes tissue contact or pressure sensors that determinewhen the jaws of an end effector initially come into contact with thetissue “T.” Contact of the jaws with tissue “T” closes a sensing circuit“SC” that is otherwise open, by establishing contacting with a pair ofopposed plates “P1, P2” provided on the jaw members.

The contact sensors may also include sensitive force transducers thatdetermine the amount of force being applied to the sensor, which may beassumed to be the same amount of force being applied to the tissue “T.”Such force being applied to the tissue may then be translated into anamount of tissue compression. In certain instances, measuring thephysiological parameter and assessing proximity of the end effector26000 to cancerous tissue can be triggered by reaching a predeterminedtissue compression threshold.

Force transducers may include, and are not limited to, piezoelectricelements, piezoresistive elements, metal film or semiconductor straingauges, inductive pressure sensors, capacitive pressure sensors, andpotentiometric pressure transducers that use bourbon tubes, capsules, orbellows to drive a wiper arm on a resistive element. FIG. 20 andadditional exemplifications are further described in U.S. Pat. No.8,181,839, filed Jun. 27, 2011, titled SURGICAL INSTRUMENT EMPLOYINGSENSORS, which issued May 5, 2012, the entire disclosure of which isincorporated by reference herein.

In certain instances, transition of the end effector 26000 to a closedconfiguration can trigger measuring the physiological parameter andassessing proximity of the end effector 26000 to cancerous tissue. Atracking system 480 (FIGS. 12 and 32), which is configured to determinethe position of a longitudinally movable displacement member thattransmits closure motions to the end effector 26000, can be employed indetecting the closed configuration.

The microcontroller 461 may consult one or more readings from one ormore of the sensors 472, 474, 476 in performing the detection 26021. Forexample, readings from the strain gauge sensor 474, which can be used tomeasure the force applied to tissue grasped by the end effector 26000,can reflect whether tissue is grasped by the end effector 26000.

In any event, if it is determined 26021 that tissue is grasped by theend effector 26000, or that a closed configuration is reached, proximityof the end effector 26000 from cancerous tissue can be ascertained 26023based upon a physiological parameter of grasped tissue. A sensor array26471 including “n” sensors, wherein “n” is an integer greater than orequal to one, can be configured to provide the microcontroller 461sensor signals according to a physiological parameter of the tissue thatindicates proximity of the end effector 26000 to cancerous tissue.

If it is determined 26024 that the proximity of the end effector tocancerous tissue reaches or crosses a predetermined threshold, steps canbe taken to alert 26025 a surgical operator and/or override 26026 atissue treatment.

The microcontroller 461 may alert the surgical operator through thedisplay 473, for example. Other audio, haptic, and/or visual means canalso be employed. The microcontroller 461 may also take steps to preventthe tissue sealing. For example, the microcontroller 461 may signal themotor driver 492 to deactivate the motor 482.

In various aspects, one or more the processes 26020 and 26120 areimplemented by program instructions stored in the memory 468, which canbe executed by the processor 462 to perform one or more of the steps ofthe processes 26020 and 26120. The microcontroller 461 may also employneural networks, look-up tables, defined functions, and/or real-timeinput from a cloud-based system 104 (FIG. 1) in performing one or moreof the steps of the processes 26020 and 26120.

In one example, the microcontroller 461 may employ a look-up table or adefined function, which can be stored in the memory 468, in correlatingsensor signals from the sensor array 26471 with values of thephysiological parameter of the grasped tissue. Look-up tables can alsodefine a proximity index for assessing proximity of the end effector26000 to cancerous tissue based upon the determined values of thephysiological parameter or, more directly, based on the received sensorsignals. FIG. 33 illustrates an example proximity index 26030, whichcorrelates sensor signal readings (R_(1-n)) received by themicrocontroller 461 from the sensor array 26471 with correspondingdistances (D_(1-n)) between the end effector and cancerous tissue.

In various instances, measuring the physiological parameter of thetissue and/or assessing proximity of an end effector 26000 to canceroustissue is triggered by a user input. A user interface such as, forexample, the display 473 can be employed to receive and transmit theuser input to the microcontroller 461, for example.

In addition to detecting proximity of an end effector to canceroustissue, it is desirable to provide a direction for navigating the endeffector sufficiently away from the cancerous tissue. FIG. 34 is a logicflow diagram of a process 26040 depicting a control program or a logicconfiguration for navigating an end effector 26050 away from canceroustissue. The end effector 26050 is similar in many respects to the endeffector 26000. For example, the surgical instrument 26010 can beequipped with an end effector 26050 in lieu of the end effector 26000.

The process 26040 can be executed alone or in combination with theprocess 26020, or at least a portion thereof. In various aspects, theprocess 26040 is executed by a control circuit of a control system 26470in communication with sensors 26055, 26056 on opposite sides 26053,26054 of an end effector 26050. The sensors 26055, 26056 are spacedapart and separated by a transection path defined by a longitudinal axis“L” extending along an elongated channel configured to accommodate atransection member movable there through. The sensors 26055, 26056 areconfigured to provide sensor signals corresponding to a physiologicalparameter indicative of proximity of the end effector 26050 to canceroustissue.

The process 26040 can be executed by program instructions stored in thememory 468, which can be executed by the processor 462 to perform theprocess 26040. The microcontroller 461 may also employ neural networks,look-up tables, defined functions, and/or real-time input from acloud-based system 104 (FIG. 1) in performing the process 26040.

The process 26040 includes receiving 26041 the sensor signals fromsensors 26055, 26056. If it is determined 26042 that the sensor signalsrepresent values of the physiological parameter greater than or equal toa predetermined threshold, the process 26040 allows 26043 a treatmentapplication to the tissue by the end effector 26050. Conversely, If itis determined 26044 that the sensor signals represent values of thephysiological parameter less than or equal to the predeterminedthreshold, the process 26040 instructs 26045 the user to move the endeffector in any suitable direction.

Further to the above, if it is determined 26046 that a first sensorsignal represents a value of the physiological parameter greater than orequal to the predetermined threshold, while a second sensor signalrepresents a value less than the predetermined threshold, the process26040 instructs the user to move the end effector 26050 in a firstdirection 26061. Conversely, if it is determined 26048 that the secondsensor signal represents a value of the physiological parameter greaterthan or equal to the predetermined threshold, while the first sensorsignal represents a value less than the predetermined threshold, theprocess 26040 instructs the user to move the end effector 26050 in asecond direction 26062, opposite the first direction 26061.

As illustrated in FIG. 35, the longitudinal axis “L” defines a firstside 26053 and a second side 26054. The first direction 26061 extendsaway from the longitudinal axis “L” on the first side 26053, while thesecond direction 26062 extends away from the longitudinal axis “L” onthe second side 26054.

FIG. 36 is a graph illustrating sensor signals from sensors 26055, 26056representing values of a physiological parameter of tissue (Y-axis)plotted against time (x-axis) for three different positions (Position A,Position B, Position C) of the end effector 26050 relative to canceroustissue. The physiological parameter is glucose level within the tissue.As described above, a low glucose level indicates a close proximity tocancerous tissue. Alternatively, the physiological parameter can be pHlevel. A low pH level indicates a close proximity to cancerous tissue.

In various examples, an end effector, in accordance with at least oneaspect of the present disclosure, may include sensors that measure twoor more physiological parameters indicative of proximity to canceroustissue. For example, an end effector may include one or more glucosesensors and one or more pH sensors. Sensor signals from sensor ofdifferent types can be received analyzed by the microcontroller 461 toassess proximity to cancerous tissue.

In Position A, sensor signals 26057, 26058 of the sensors 26055, 26056are greater than or equal to the predetermined threshold “N.”Accordingly, it can be concluded that the cancerous tissue issufficiently far away from the end effector 26050. Accordingly, themicrocontroller 461 may inform the surgical operator that is safe totreat tissue grasped by the end effector 26050.

In position C, the signals 26057, 26058 of the sensors 26055, 26056 areless than the predetermined threshold “N.” Accordingly, it can beconcluded that the tumor is on, or at least near, the transection path26052 between the sensors 26055, 26056. Accordingly, the microcontroller461 may instruct the surgical operator to release the grasped tissue,and reposition the end effector 26050 by moving it to the side in eitherdirection, before application of a treatment to the tissue.

In position B, the sensor signal 26057 of the sensor 26055 is below thepredetermined threshold “N,” while the sensor signal 26058 of the sensor26056 is greater than the predetermined threshold “N.” Accordingly, itcan be concluded that the tumor extends on the first side 56053 of theend effector 26050. Accordingly, the microcontroller 461 may instructthe surgical operator to release the grasped tissue, and reposition theend effector 26050 by moving it in the second direction 26062 away fromthe cancerous tissue, before treating the tissue.

In various examples, the sensor signals are directly proportional to thephysiological parameter detected by the sensors. In other equivalentexamples, however, the sensor signals can be inversely proportional tothe physiological parameter detected by the sensors. In such otherexamples, the sensor signals decrease as the proximity to canceroustissue increases. Nonetheless, an inverter can be utilized to invert thereceived sensor signals.

In various aspects, referring to FIGS. 32, 35, and 36, themicrocontroller 461 further processes the sensor signals of the sensors26055, 26056 by subtracting one sensor signal from the other sensorsignal. The resulting delta can be further analyzed to determine thedirection in which the end effector 26050 is to be moved. As illustratedin FIG. 36, in position A and position C, the sensor signals mostlycancel each other out. However, in position B of FIG. 36, a positive inthe delta 26059 is detected. The delta positive transition indicatesthat the cancerous tissue extends on the first side 26053 of the endeffector 26050 but not the second side 26054. In addition, whether thedelta 26059 is above or below zero can give an indication as to thedesired direction of motion for the end effector 26050.

With sensors 26055, 26056, as illustrated in the example of FIG. 35, themicrocontroller 461 is able to assess relevant proximity to cancerousand determine how to navigate away from the cancerous tissue direction.In other example, a sensor array may include more than two sensors. Inone example, a sensor array may include, in addition to the sensors26055, 26056, a third sensor at a distal portion of the end effector.

In various aspects, as illustrated in FIG. 37, an end effector 26070 maybe equipped with a sensor array 26080 that includes six sensors(Sen₁-Sen₆): two proximal sensors (Sen₁ and Sen₆), two medial sensors(Sen₂ and Sen₅), and two distal sensors (Sen₃ and Sen₄). The addedsensors allow the microcontroller 461, among other things, to moreaccurately predict the position of the end effector 26070 with respectto cancerous tissue.

The end effector 26070 is similar in many respects to the end effectors26000, 26050. For example, the end effector 26070 includes a first jaw26071 and a second jaw 26072. At least one of the first jaw 26071 andthe second jaw 26072 is movable relative to the other to grasp tissuetherebetween.

Further to the above, the end effector 26070 includes an anvil definedin the second jaw 26072 and a staple cartridge 26075 defined in thefirst jaw 26071. To treat tissue grasped by the end effector 26070,staples are deployed from the staple cartridge 26075 into the graspedtissue, and are deformed by the anvil. To cut the tissue, a transectionmember is moved relative to an elongated slot that defines a transectionpath 26073 for the transection member. The transection path 26073defines two opposite sides 26076, 26077 of the end effector 26070.

Further to the above, the sensor array 26080 is similar in many respectsto the sensor array 26471. For example, the sensor array 26080 can alsobe coupled to the microcontroller 461. The sensor array 26080 includessix sensors (Sen₁-Sen₆) configured to provide the microcontroller 461with sensor signals according to a physiological parameter of the tissuethat indicates proximity of the end effector 26070 to cancerous tissue.In other examples, the sensor array 26080, like the sensor array 26471,may include more or less than six sensors.

The sensors of the sensor array 26080 are spaced apart and arranged onouter edges 26078, 26079 of the staple cartridge 26075. In the exampleof FIG. 37, Sen₁, Sen₂, and Sen₃ are arranged on the side 26076 whileSen₄, Sen₅, and Sen₆ are arranged on the side 26077. In other words, thetransection path 26052 extends between the sensors of the sensor array26080.

In various examples, the differential between the sensor signals and themean of the signals can give insight into tumor proximity. If a signalindicates a sensor is on a tumor, the differential between that sensorand the other sensors will give insight if the tumor is along one side(not transected) or across the transection path (transected). If thedifferential between the signals and mean is small but the mean is high,the entire end effector is on the tumor.

FIGS. 38 and 41 are graphs illustrating sensor signals of sensorsSen₁-Sen₆ plotted on the Y-axis against time on the x-axis. The sensorsignals of sensors Sen₁-Sen₆ measure a physiological parameter thatchanges with a change in distance from cancerous tissue. Accordingly,the sensor signals of Sen₁-Sen₆ represent a physiological parameter oftissue indicative of the position of the end effector 26070 with respectto cancerous tissue.

Error! No sequence specified. The physiological parameter of FIGS. 38and 41 is one that decreases with an increase in proximity to canceroustissue, but the sensor signals of sensors Sen₁-Sen₆ were passed throughan inverter. Each of the positions A-C of FIG. 38 and the positions A-Eof FIG. 40 represents a distinct position of the end effector 26070 withrespect to the cancerous tissue.

In the examples of FIGS. 38 and 41, an average (AVG) of the sensorsignals may calculate microcontroller 461 from the formula:

${{AVG} = \frac{{Sen}_{1} + {Sen}_{2} + {{Sen}_{3}\mspace{14mu} \ldots \mspace{14mu} {Sen}_{n}}}{n}},$

wherein Sen_(1-n) represent sensor signal values at time (t), andwherein (n) represent the number of sensors.

Then, the microcontroller 461 may employ a formula:

Σ|Sen_(n)−AVG|<X

, wherein (n) is an integer greater than zero, wherein (AVG) is theaverage of the sensor signals, and wherein (x) is a predeterminedthreshold, to determine proximity of the end effector 26070 to canceroustissue. If the formula yields an outcome below the predeterminedthreshold (x), as illustrated in Positions A of FIGS. 38 and 41, themicrocontroller 461 authorizes a tissue treatment by the end effector26070. In positions B-D of FIG. 38 and positions B-E of FIG. 41, theformula yields an outcome that is greater than the predeterminedthreshold (x) indicating that one or more of the sensors are within aclose proximity to the cancerous tissue.

The microcontroller 461 may compare the sensor signal of each of thesensors Sen₁-Sen₆ to the average of the sensor signals (AVG) to assessproximity of the sensors Sen₁-Sen₆ to cancerous tissue. The proximity ofthe end effector 26070 to tissue can be inferred from the assessedproximity of the sensors Sen₁-Sen₆ to cancerous tissue. The sensorsproviding sensor signals greater than (AVG) can be identified as sensorspositioned within close proximity to the cancerous tissue. Othermathematical formulas can be applied to the sensor signals of thesensors Sen₁-Sen₆ to ascertain proximity of the sensors Sen₁-Sen₆ tocancerous tissue.

Further to the above, additional information can also be inferred fromthe spatial relation of the sensors Sen₁-Sen₆ on the end effector 26070.FIG. 39 is a logic flow diagram of a process 26090 depicting a controlprogram or a logic configuration that provides instructions fornavigating an end effector with respect to cancerous tissue, wherein theinstructions are based on the spatial relation of sensors on the endeffector that report readings indicative of close proximity of thesensors to cancerous tissue. The process 26090 can be executed by themicrocontroller 461 based on sensor readings from the sensors Sen₁-Sen₆.The process 26090 includes receiving 26091 sensor signals from sensorsSen₁-Sen₆, and determining 26092, based on the above-described formulas,the sensors with close proximity to cancerous tissue. Furthermore, theprocess 26090 includes providing 26092 instructions for navigating anend effector 26050 away from the cancerous tissue based on the relativelocation of the sensors with close proximity to cancerous tissue on theend effector 26050.

Position C of FIG. 38 and Position B of FIG. 41 illustrate an examplethat implements the process 26090 of FIG. 39. In Position C of FIG. 38and Position B of FIG. 41, the readings of Sen₃ and Sen₄ are greaterthan (AVG) while the remaining sensors report readings below (AVG). Inaddition, the Sen₃ and Sen₄ are located at a distal portion of the endeffector 26070 on opposite sides 26076 and 26077. Accordingly, it can beconcluded that the cancerous tissue extends over the transection path26073, and is mainly located in front of the end effector 26070. Inresponse, the microcontroller 461 may instruct the surgical operator torelease the grasped tissue, and move the end effector 26070 backward toreach a clear margin before re-grasping the tissue.

Position D of FIG. 38 illustrates another example that implements theprocess 26090 of FIG. 39. In Position D of FIG. 38, the readings of Sen₃and Sen₂ are greater than (AVG) while the remaining sensors reportreadings below (AVG). In addition, Sen₂ and Sen₃ are positioned on thesame side 26076 of the end effector 26070. Accordingly, it can beconcluded the cancerous tissue extends on the side 26076 of the endeffector 26070. Since the readings of Sensors Sen₄, Sen₅, and Sen₆,which are located on the side 26077, indicate that these sensors are notin close proximity to cancerous tissue, the microcontroller 461 mayinstruct the surgical operator to release the grasped tissue, and movethe end effector 26070 in a direction away from the transection path26073 on the side 26077 in order to reach a clear margin on the side26076.

FIG. 40 is a logic flow diagram of a process 26190 depicting a controlprogram or a logic configuration that provides instructions fornavigating an end effector with respect to cancerous tissue, wherein theinstructions are based on the spatial relation and comparison of valuesof readings of sensors on the end effector that report readingsindicative of close proximity of the sensors to cancerous tissue. Theprocess 26190 can be executed by the microcontroller 461 based on sensorreadings from the sensors Sen₁-Sen₆. The process 26190 includesreceiving 26191 sensor signals from sensors Sen₁-Sen₆, and determining26192, based on the above-described formulas, the sensors with closeproximity to cancerous tissue. Furthermore, the process 26190 includesproviding 26193 instructions for navigating an end effector 26070 awayfrom the cancerous tissue based on the relative location and relativevalues of the readings of the sensors with close proximity to canceroustissue on the end effector 26070.

Position E of FIG. 41 provides an example that implements the process26190. In Position E of FIG. 41, the readings of Sen₁, Sen₂, and Sen₃are all greater than or equal to (AVG) while the remaining sensorsreport readings below (AVG). In addition, Sen₁, Sen₂, and Sen₃ are allpositioned on the side 26076 of the end effector 26070. Accordingly, itcan be concluded that the cancerous tissue extends on the side 26076 ofthe end effector 26070. In addition, the reading of Sen₂ is greater thanthe reading of Sen₁. Also, the reading of Sen₂ is greater than thereading of Sen₃. Since Sen₂is positioned between Sen₁ and Sen₃ on thesame side 26076, I can be concluded that the cancerous tissue extends onthe side 26076 of the end effector 26070 at a position closer to Sen₂than Sen₁ and Sen₃.

In various examples the sensors of a sensor array such as the sensorarray 26471 and/or the sensor array 26080 can be integrated into astaple cartridge and conducted through metallic portions of the staplecartridge that, when assembled with an end effector, engage contactorplates that transmit power and/or data.

In various examples, the physiological parameter of the tissue that ismeasured by the sensors of a sensor array, in accordance with thepresent disclosure, is pH. As discussed above, lactic acid is abyproduct of the glycolysis (anaerobic metabolism) process that isperformed by cancerous tissue leading to decreased glucose and increasedlactic acid in the interstitial fluid environment.

In various examples, the physiological parameter of the tissue that ismeasured by the sensors of a sensor array, in accordance with thepresent disclosure, is glucose. As described above, glucose levels havebeen measured to be very low in tumor microenvironments (0.1-0.4 mM). Innormal tissue, glucose levels can be in the range of about 3.3-5.5 mM.

In various examples, the sensors of a sensor array, in accordance withthe present disclosure, are Clark-type sensors, which can be used tomeasure glucose levels based on oxygen reaction with an enzyme.Clark-type sensors use an immobilized glucose oxidase embedded surfaceto catalyze the oxidation of beta-D-glucose to produce gluconic acid andhydrogen peroxide. Hydrogen peroxide is oxidized at a catalytic (usuallyplatinum) anode which induces an electron transfer proportional to thenumber of glucose molecules present.

FIGS. 42 and 43 illustrate an example thick-film printed glucose sensor26200, which can be employed with a sensor array of the presentdisclosure. This configuration uses iridium doped carbon ink, which hashigh specificity towards glucose detection that is not obscured by othercommon interference chemicals (e.g., ascorbic acid). The sensor 26200comprises an electrode diameter of ˜1 mm. In one example, as illustratedin FIG. 43, the sensor 26200 includes an Ir-Carbon counter electrode26202, and Ir-Carbon working electrode 26203, an Ag/AgCl referenceelectrode 26204, and a silver conducting pad 26205. In addition, thesensor 26200 further includes an insulating layer 26206. Additionaldetails of the sensor 26200 are described in a journal publication toShen J et al., titled Sensors and Actuators B: Chemical, 2007, V125(1),pp. 16-113, which is incorporated by reference herein in its entirety.As illustrated in FIGS. 44-45, with an applied potential of 0.2-0.3V, aresponse current of ˜15-20 uA can be observed with an increase of 5 mMof glucose.

In various aspects, the sensors of a sensor array, in accordance withthe present disclosure, can be placed on a staple cartridge. An adhesivemask can be embedded with the sensors at predetermined locations. Invarious aspects, the sensors are attached to bumps on the staplecartridge so that the sensors are positioned higher than a cartridgedeck of the staple cartridge to ensure contact with the tissue. Theadhesive mask could be created in bulk using screen-printing technologyon a polyester substrate, for example. Conducting pads can be printed toa common location.

In various examples, in addition to detection of proximity to canceroustissue, an end effector of the present disclosure can also be configuredto target specific cancer types in specific tissues. As indicated in thejournal publication to Altenberg B and Greulich K O, Genomics 84(2004)pp. 1014-1020, which is incorporated herein by reference in itsentirety, certain cancers are characterized by an overexpression ofglycolysis genes while other cancers are not characterized by anoverexpression of glycolysis genes. Accordingly, an end effector of thepresent disclosure can be equipped with a sensor array with a highspecificity for cancerous tissue characterized by an overexpression ofglycolysis genes such as lung cancer or liver cancer.

In various aspects, the sensor readings of a sensor array, in accordancewith the present disclosure, are communicated by the surgical instrumentto a surgical hub (e.g., surgical hub 106, 206) for additional analysisand/or for situational awareness.

Situational Awareness

Situational awareness is the ability of some aspects of a surgicalsystem to determine or infer information related to a surgical procedurefrom data received from databases and/or instruments. The informationcan include the type of procedure being undertaken, the type of tissuebeing operated on, or the body cavity that is the subject of theprocedure. With the contextual information related to the surgicalprocedure, the surgical system can, for example, improve the manner inwhich it controls the modular devices (e.g., a robotic arm and/orrobotic surgical tool) that are connected to it and providecontextualized information or suggestions to the surgeon during thecourse of the surgical procedure.

Referring now to FIG. 46, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206, for example, isdepicted. The timeline 5200 is an illustrative surgical procedure andthe contextual information that the surgical hub 106, 206 can derivefrom the data received from the data sources at each step in thesurgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

At the first step 5202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step 5204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step 5206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step 5208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step 5210, the staff members attach the electrocardiography (EKG)electrodes and other patient monitoring devices to the patient. The EKGelectrodes and other patient monitoring devices are able to pair withthe surgical hub 106, 206. As the surgical hub 106, 206 begins receivingdata from the patient monitoring devices, the surgical hub 106, 206 thusconfirms that the patient is in the operating theater.

Sixth step 5212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step 5214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step 5216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step 5204of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step 5220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step 5224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step 5224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step 5226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step 5228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, blood pressure, and other datafrom the patient monitoring devices. As can be seen from the descriptionof this illustrative procedure, the surgical hub 106, 206 can determineor infer when each step of a given surgical procedure is taking placeaccording to data received from the various data sources that arecommunicably coupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is incorporated by reference herein in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the hub 106, 206 based on its situationalawareness and/or feedback from the components thereof and/or based oninformation from the cloud 104.

EXAMPLES

Various aspects of the subject matter described herein are set out inthe following numbered examples.

Example 1

A surgical instrument is disclosed. The surgical instrument comprises anend effector and a control circuit. The end effector comprises a firstjaw, a second jaw movable relative to the first jaw to grasp tissuetherebetween, an anvil, a staple cartridge comprising staples deployableinto the tissue, wherein the staples are deformable by the anvil, and asensor configured to provide a sensor signal according to aphysiological parameter of the tissue. The control circuit is coupled tothe sensor, wherein the control circuit is configured to receive thesensor signal, and assess proximity of the sensory to cancerous tissuebased on the sensor signal.

Example 2

The surgical instrument of Example 1, wherein the control circuit isfurther configured to generate an alert in the event the proximity ofthe sensor to cancerous tissue reaches or crosses a predeterminedthreshold.

Example 3

The surgical instrument of any one of Examples 1 and 2, wherein thecontrol circuit is further configured to prevent deployment of thestaples in the event the proximity of the sensor to cancerous tissuereaches or crosses a predetermined threshold.

Example 4

The surgical instrument of any one of Examples 1-3, further comprising amotor configured to cause deployment of the staples, wherein the controlcircuit is further configured to prevent activation of the motor in theevent the value of the physiological parameter reaches or crosses apredetermined threshold.

Example 5

The surgical instrument of any one of Examples 1-4, wherein thephysiological parameter is tissue glucose level.

Example 6

The surgical instrument of any one of Examples 1-4, wherein thephysiological parameter is tissue pH level.

Example 7

The surgical instrument of any one of Examples 1-6, wherein the sensoris a Clark-type sensor.

Example 8

The surgical instrument of any one of Examples 1-7, wherein the controlcircuit is further configured to provide instructions to move the endeffector in a predetermined direction away from the cancerous tissue.

Example 9

A surgical stapling instrument is disclosed. The surgical staplinginstrument comprises an end effector and a control circuit. The endeffector comprises a first jaw, a second jaw movable relative to thefirst jaw to grasp tissue therebetween, an anvil, a staple cartridgecomprising staples deployable into the tissue, wherein the staples aredeformable by the anvil, and a sensor configured to provide a sensorysignal according to a physiological parameter indicative of proximity ofthe sensor to cancerous tissue. The control circuit is coupled to thesensor, wherein the control circuit is configured to receive the sensorsignal, determine a value of the physiological parameter based on thesensor signal, and compare the value of the physiological parameter to apredetermined threshold.

Example 10

The surgical stapling instrument of Example 9, wherein the controlcircuit is further configured to generate an alert based on comparingthe value of the physiological parameter to a predetermined threshold.

Example 11

The surgical stapling instrument of any one of Examples 9 and 10,wherein the control circuit is further configured to prevent deploymentof the staples in the event the value of the physiological parameterreaches or crosses the predetermined threshold.

Example 12

The surgical stapling instrument of any one of Examples 9-11, furthercomprising a motor configured to cause deployment of the staples,wherein the control circuit is further configured to prevent activationof the motor in the event the value of the physiological parameterreaches or crosses the predetermined threshold.

Example 13

The surgical stapling instrument of any one of Examples 9-12, whereinthe physiological parameter is tissue glucose level.

Example 14

The surgical stapling instrument of any one of Examples 9-12, whereinthe physiological parameter is tissue pH level.

Example 15

The surgical stapling instrument of any one of Examples 9-14, whereinthe sensor is a Clark-type sensor.

Example 16

The surgical stapling instrument of any one of Examples 9-15, whereinthe control circuit is further configured to provide instructions tomove the end effector in a predetermined direction away from thecancerous tissue.

Example 17

A surgical instrument is disclosed. The surgical instrument comprises anend effector and a control circuit. The end effector comprises a firstjaw, a second jaw movable relative to the first jaw to grasp tissuetherebetween, an anvil, a staple cartridge comprising staples deployableinto the tissue, wherein the staples are deformable by the anvil, and asensor assembly configured to provide sensor signals according to aphysiological parameter indicative of proximity of the sensors tocancerous tissue. The sensor assembly comprises a first sensor on afirst side of a longitudinal axis extending through the staple cartridgeand a second sensor on a second side of the longitudinal axis. Thecontrol circuit is coupled to the sensor assembly, wherein the controlcircuit is configured to receive a first sensor signal from the firstsensor, receive a second sensor signal from the second sensor, determinea first value of the physiological parameter based on the first sensorsignal, determine a second value of the physiological parameter based onthe second sensor signal, and compare the first value and the secondvalue to a predetermined threshold.

Example 18

The surgical instrument of Example 17, wherein the control circuit isfurther configured to provide instructions to move the end effector in afirst direction in the event the first value but not the second valuereaches or crosses the predetermined threshold, and wherein the firstdirection extends away from the longitudinal axis on the first side.

Example 19

The surgical instrument of Example 18, wherein the control circuit isfurther configured to provide instructions to move the end effector in asecond direction in the event the second value but not the first valuereaches or crosses the predetermined threshold, and wherein the seconddirections extends away from the longitudinal axis on the second side.

Example 20

The surgical instrument of Example 19, wherein the control circuit isfurther configured to approve position of the end effector in the eventthe first value and the second value are below the predeterminedthreshold.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module,”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard,” published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical,” “horizontal,” “up,” and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation, no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which that fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

What is claimed is:
 1. A surgical instrument, comprising: an endeffector, comprising: a first jaw; a second jaw movable relative to thefirst jaw to grasp tissue therebetween; an anvil; a staple cartridgecomprising staples deployable into the tissue, wherein the staples aredeformable by the anvil; and a sensor configured to provide a sensorsignal according to a physiological parameter of the tissue; a controlcircuit coupled to the sensor, wherein the control circuit is configuredto: receive the sensor signal; and assess proximity of the sensor tocancerous tissue based on the sensor signal.
 2. The surgical instrumentof claim 1, wherein the control circuit is further configured togenerate an alert in the event the proximity of the sensor to canceroustissue reaches or crosses a predetermined threshold.
 3. The surgicalinstrument of claim 1, wherein the control circuit is further configuredto prevent deployment of the staples in the event the proximity of thesensor to cancerous tissue reaches or crosses a predetermined threshold.4. The surgical instrument of claim 1, further comprising a motorconfigured to cause deployment of the staples, wherein the controlcircuit is further configured to prevent activation of the motor in theevent the value of the physiological parameter reaches or crosses apredetermined threshold.
 5. The surgical instrument of claim 1, whereinthe physiological parameter is tissue glucose level.
 6. The surgicalinstrument of claim 1, wherein the physiological parameter is tissue pHlevel.
 7. The surgical instrument of claim 1, wherein the sensor is aClark-type sensor.
 8. The surgical instrument of claim 1, wherein thecontrol circuit is further configured to provide instructions to movethe end effector in a predetermined direction away from the canceroustissue.
 9. A surgical stapling instrument, comprising: an end effector,comprising: a first jaw; a second jaw movable relative to the first jawto grasp tissue therebetween; an anvil; a staple cartridge comprisingstaples deployable into the tissue, wherein the staples are deformableby the anvil; and a sensor configured to provide a sensor signalaccording to a physiological parameter indicative of proximity of thesensor to cancerous tissue; a control circuit coupled to the sensor,wherein the control circuit is configured to: receive the sensor signal;determine a value of the physiological parameter based on the sensorsignal; and compare the value of the physiological parameter to apredetermined threshold.
 10. The surgical instrument of claim 9, whereinthe control circuit is further configured to generate an alert based oncomparing the value of the physiological parameter to a predeterminedthreshold.
 11. The surgical instrument of claim 9, wherein the controlcircuit is further configured to prevent deployment of the staples inthe event the value of the physiological parameter reaches or crossesthe predetermined threshold.
 12. The surgical instrument of claim 9,further comprising a motor configured to cause deployment of thestaples, wherein the control circuit is further configured to preventactivation of the motor in the event the value of the physiologicalparameter reaches or crosses the predetermined threshold.
 13. Thesurgical instrument of claim 9, wherein the physiological parameter istissue glucose level.
 14. The surgical instrument of claim 9, whereinthe physiological parameter is tissue pH level.
 15. The surgicalinstrument of claim 9, wherein the sensor is a Clark-type sensor. 16.The surgical instrument of claim 9, wherein the control circuit isfurther configured to provide instructions to move the end effector in apredetermined direction away from the cancerous tissue.
 17. A surgicalinstrument, comprising: an end effector, comprising: a first jaw; asecond jaw movable relative to the first jaw to grasp tissuetherebetween; an anvil; a staple cartridge comprising staples deployableinto the tissue, wherein the staples are deformable by the anvil; and asensor assembly configured to provide sensor signals according to aphysiological parameter indicative of proximity of the sensors tocancerous tissue, wherein the sensor assembly comprises: a first sensoron a first side of a longitudinal axis extending through the staplecartridge; and a second sensor on a second side of the longitudinalaxis; a control circuit coupled to the sensor assembly, wherein thecontrol circuit is configured to: receive a first sensor signal from thefirst sensor; receive a second sensor signal from the second sensor;determine a first value of the physiological parameter based on thefirst sensor signal; determine a second value of the physiologicalparameter based on the second sensor signal; and compare the first valueand the second value to a predetermined threshold.
 18. The surgicalinstrument of claim 17, wherein the control circuit is furtherconfigured to provide instructions to move the end effector in a firstdirection in the event the first value but not the second value reachesor crosses the predetermined threshold, and wherein the first directionextends away from the longitudinal axis on the first side.
 19. Thesurgical instrument of claim 18, wherein the control circuit is furtherconfigured to provide instructions to move the end effector in a seconddirection in the event the second value but not the first value reachesor crosses the predetermined threshold, and wherein the second directionextends away from the longitudinal axis on the second side.
 20. Thesurgical instrument of claim 19, wherein the control circuit is furtherconfigured to approve position of the end effector in the event thefirst value and the second value are below the predetermined threshold.